FOI Documents 200-000 - 200-999
Listed with Abstracts from the Summaries
ANADA 200-007 original approval
Sponsor: Happy Jack® Inc.
Generic Name: pyrantel pamoate
Trade Name: Liqui-Vict 2X™
Indications for Use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
For removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies.
Date of Approval: October 30, 1996
ANADA 200-008 original approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200, BIO-MYCIN® 200
Indications for Use: OXY-TET 200/BIO-MYCIN 200 is intended for use in the treatment of the following diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms. CATTLE: OXY-TET 200 is indicated in the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis ; foot rot and diphtheria caused by Fusobacterium necrophorum ; bacterial enteritis (scours) caused by Escherichia coli ; wooden tongue caused by Actinobacillus lignieresi ; leptospirosis caused by Leptospira pomona ; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. SWINE: In swine, OXY-TET 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli ; pneumonia caused by Pasteurella multocida ; and leptospirosis caused by Leptospira pomona . In sows, OXY-TET 200 is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
Date of Approval: November 16, 1994
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: To add the subcutaneous route of administration to the label for cattle.
Date of Approval: May 22, 1996
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Animal Health, Inc.
Generic Name: oxytetracycline injection
Trade Name: OXY-TET™ 200; BIO-MYCIN® 200
Effect of Supplement: This supplemental application establishes a 28 day withdrawal period for subcutaneous use in cattle and intramuscular use in swine (all approved routes of administration in cattle and swine).
Date of Approval: March 16, 1999
ANADA 200-008 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Oxytetracycline injection
Trade Name: BIO-MYCIN® 200
Effect of Supplement: This supplemental application provides for the use in lactating cattle.
Date of Approval: September 3, 2002
ANADA 200-023 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: gentamicin sulfate solution
Trade Name: Gentamicin Sulfate Solution 100 mg/mL
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: August 4, 1995
ANADA 200-026 original approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Indications for Use: Control of certain diseases caused by bacteria susceptible to oxytetracycline hydrochloride.
Date of Approval: March 13, 1997
ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: oxytetracylcline hydrochloride
Trade Name: Pennox 343
Effect of Supplement: Revised withdrawal period (0-day) in turkeys & additional package size of 23.9 oz..
Date of Approval: February 5, 1999
ANADA 200-026 supplemental approval
Sponsor: PennField Oil Company
Generic Name: Oxytetracycline hydrochloride
Trade Name: Pennox™ 343
Effect of Supplement: Revised withdrawal period (0-day) in swine
Date of Approval: April 10, 2002
ANADA 200-027 supplemental approval
Sponsor: Planalquimica Industrial Ltd
Generic Name: nicarbazin
Trade Name: Nicarmix (nicarbazin) 25%
Effect of Supplement: This supplement approves Nicarmix (nicarbazin) 25%, as manufactured by Planalquimica, as an equivalent to nicarbazin sold by Merck.
Date of Approval: May 30, 1995
ANADA 200-028 original approval
Sponsor: LAMBERT KAY
Generic Name: Pyrantel pamoate
Trade Name: Evict®, Lassie®, Vet's Own™
Indications for Use: Evict® should be used to prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping and for removal of large roundworms and hookworms in dogs and puppies.
Date of Approval: March 28, 1996
ANADA 200-028 supplemental approval
Sponsor: Lambert-Kay
Generic Name: pyrantel pamoate
Trade Name: Evict® DS and Lassie® DS Liquid Wormer plus Vet's Own™ DS Canine Anthelmintic Suspension
Effect of Supplement: Provides for a double strength pyrantel pamoate suspension.
Date of Approval: June 4, 1997
ANADA 200-029 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: ketamine hydrochloride injection
Trade Name: Ketamine Hydrochloride Injection
Indications for Use: Ketamine Hydrochloride Injection may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 16, 1995
ANADA 200-030 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine 12.5% oral solution
Trade Name: Sulfadimethoxine 12.5% Oral Solution
Indications for Use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. FOR DAIRY CALVES, DAIRY HEIFERS AND BEEF CATTLE: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: December 31, 1992
ANADA 200-031 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Antibacterial Soluble Powder
Indications for Use: BROILER AND REPLACEMENT CHICKENS: Indicated for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. MEAT PRODUCING TURKEYS: Indicated for the treatment of disease outbreaks of coccidiosis and fowl cholera. DAIRY CALVES, DAIRY HEIFERS AND BEEF: Indicated for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: June 17, 1992
ANADA 200-033 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: trimethoprim/sulfadiazine
Trade Name: Uniprim Powder
Indications for Use: For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections and abscesses.
Date of Approval: June 11, 1993
ANADA 200-037 original approval
Sponsor: AgriLabs, Ltd.
Generic Name: gentamicin 100 mg/mL solution
Trade Name: Gentamicin Sulfate Solution
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: February 8, 1993
ANADA 200-038 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: sulfadimethoxine
Trade Name: Sulfadimethoxine Injection 40%
Indications for Use: Recommended in cattle for the treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , sensitive to sulfadimethoxine.
Date of Approval: May 25, 1993
ANADA 200-042 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: Ketaject®
Indications for Use: Ketaject® (ketamine hydrochloride injection. USP) may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: June 30, 1994
ANADA 200-046 original approval
Sponsor: Pfizer Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Soluble Powder 325 gm/lb
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep, and goats.
Date of Approval: May 15, 1992
ANADA 200-046 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Sulfate Soluble Powder 325 g/lb
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996
ANADA 200-049 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: tetracycline hydrochloride
Trade Name: TETRACYCLINE HYDROCHLORIDE SOLUBLE POWDER-324
Indications for Use: For use in the control and treatment of the following conditions in swine, calves and poultry. SWINE: Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. Bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., Hemophilus spp. and Klebsiella spp. susceptible to tetracycline. CHICKENS: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli ; infectious synovitis caused by Mycoplasma synoviae susceptible to tetracycline. TURKEYS: Control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, corona viral enteritis) caused by complicating bacterial organisms susceptible to tetracycline.
Date of Approval: September 30, 1993
ANADA 200-050 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: February 15, 1995
ANADA 200-050 supplemental approval
Sponsor: Rhone-Merieux, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: To increase the tolerance in the target tissue, kidneys, to 7.2 ppm and to decrease the withdrawal periods to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats.
Date of Approval: April 03, 1996
ANADA 200-050 supplemental approval
Sponsor: Bimeda, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin 325 Soluble Powder
Effect of Supplement: This supplement provides for use of the addition of a new species, turkeys..
Date of Approval: July 10 2002
ANADA 200-055 original approval
Sponsor: Lloyd Incorporated
Generic Name: ketamine hydrochloride solution, USP
Trade Name: VetaKet ™
Indications for Use: VetaKetTM may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: August 3, 1998
ANADA 200-061 original approval
Sponsor: AgriLabs
Generic Name: flunixin meglumine
Trade Name: (to be established)
Indications for Use: "Tradename" (flunixin meglumine) Solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Date of Approval: September 11, 1996
ANADA 200-061 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: flunixin meglumine
Trade Name: Flunixin Meglumine Solution
Effect of Supplement: This supplement provides for the addition of a claim for intravenous use in beef cattle and nonlactating dairy cattle to the labeling of the approved product Flunixin Meglumine Solution. The exclusivity period protecting this claim for the pioneer product expired on May 6, 2001.
Date of Approval: July 29, 2004
ANADA 200-066 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: oxytetracycline hydrochloride
Trade Name: Agrimyn™-343 Soluble Powder
Indications for Use: CHICKENS - INDICATIONS: Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 200-400 mg/gal. Control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli . Dosage: 400-800-mg/gal. Control of fowl cholera caused by Pasteurella multocida . Dosage: 400-800-mg/gal. TURKEYS- INDICATIONS: Control of Hexamitiasis caused by Hexamita meleagridis . Dosage: 200-400 mg/gal. Control of infectious synovitis caused by Mycoplasma synoviae . Dosage: 400 mg/gal. Growing turkeys: Control of body weight complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) Dosage: 25 mg/lb. SWINE - INDICATIONS: FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE: Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis , susceptible to oxytetracycline. Bacterial pneumonia caused by Pasteurella multocida , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona , susceptible to oxytetracycline. Dosage: 10 mg/lb body weight. GENERAL DIRECTIONS: Mix fresh solutions daily. Use as sole source of drinking water. Do not mix this product directly with milk or milk replacers. Administer one hour before or two hours after feeding milk or milk replacers. Consult a poultry diagnostic laboratory or poultry pathologist for diagnosis or advice on dosage for chickens or turkeys. As a generalization, 200 chickens will drink one gallon of water per day for each week of age. Turkeys will consume twice that amount. Administer up to 5 days to swine and 7 to 14 days for chickens and turkeys.
Date of Approval: July 15, 1994
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline HCl
Trade Name: AGRIMYCIN® 343 SOLUBLE POWDER
Effect of Supplement: Revised withdrawal period for turkeys and swine.Under the provisions of the Federal Food, Drug, and Cosmetic Act, as amended by the Generic Animal Drug and Patent Term Restoration Act, (53 FR 50460, December 15, 1988, First GADPTRA Policy Letter) an abbreviated new animal drug application (ANADA) may be submitted for a generic version of an approved new animal drug (pioneer product). New target animal safety data, drug effectiveness data, and human food safety data (other than tissue residue data) are not required for approval of an ANADA. An ANADA relies on the target animal safety, drug effectiveness, and human food safety data in the pioneer's new animal drug application. Ordinarily, the ANADA sponsor shows that the generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study, then a tissue residue study to establish the withdrawal time for the generic product is also required. For certain dosage forms, the agency will grant a waiver from conducting an in vivo bioequivalence study (55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter; Bioequivalence Guideline, April 1990).Based upon the formulation characteristics of the genetic product, Agri Laboratories Ltd. was granted a waiver from conducting an in vivo bioequivalence study for Oxytetracycline HCl Soluble Powder. The genetic and pioneer products contain the same active ingredient and are water soluble powders administered as oral solutions. The genetic product contains no inactive ingredients that may significantly affect the absorption of the active ingredient.
Date of Approval: October 04, 2001
ANADA 200-066 supplemental approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Agrimycin® 166
Effect of Supplement: The supplement provides for approval of an additional packet size, 9.87 oz [280 g], a different trade name, an alternate concentration of active ingredient and a change in the inactive ingredients in the finished dosage form.
Date of Approval: June 30, 2004
ANADA 200-068 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE Hydrochloride Injection
Indications for Use: OXYTETRACYCLINE HCLINJECTABLE SOLUTION is for treatment of: Pasteurella spp. -- Bacterial pneumonia and shipping fever complex associated with Pasteurella spp.; Escherichia coli -- Bacterial enteritis (scours); Spherophorous necrophorus -- Necrotic pododermatitis (foot rot), calf diphtheria; Actinobacillus lignierseii -- Wooden tongue; wound infection,acute metritis, and traumatic injury -- caused by oxytetracycline susceptible strains of streptococcal and staphylococcal bacteria.
Date of Approval: July 31, 1995
ANADA 200-069 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: gonadorelin diacetate tetrahydrate injection
Trade Name: Fertelin™ (Gonadorelin Diacetate Tetrahydrate) Sterile Solution
Indications for Use: Fertelin (Gonadorelin) is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.Historically, cyctic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Fertelin initiates release of endogenous LH to cause ovulation and luteinization
Date of Approval: August 01, 2002
ANADA 200-070 original approval
Sponsor: Abbott Laboratories
Generic Name: isoflurane, USP
Trade Name: IsoFlo™
Indications for Use: IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
Date of Approval: March 11, 1993
ANADA 200-071 original approval
Sponsor: Delmarva Laboratories, Incorporated
Generic Name: pentobarbital sodium and phenytoin sodium
Trade Name: Euthasol™
Indications for Use: For use in dogs for humane, painless, and rapid euthanasia
Date of Approval: February 24, 1994
ANADA 200-073 original approval
Sponsor: American Veterinary Products, Inc.
Generic Name: ketamine hydrochloride injection, USP
Trade Name: ketamine hydrochloride injection, USP
Indications for Use: Ketamine hydrochloride injection, USP may be used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: July 21, 1994
ANADA 200-075 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati
Date of Approval: February 23, 1994
ANADA 200-075 supplemental approval
Sponsor: Intervet Inc.
Generic Name: salinomycin sodium
Trade Name: Sacox®
Indications for Use: To add roaster and replacement (breeder and layer) chickens to the label claim for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and to add quail to the label claim for the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae.
Date of Approval: November 8, 2002
ANADA 200-080 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: Salinomycin sodium, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Bambermycins
Trade Name: Sacox, 3-Nitro, Roxarsone, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: March 8, 1994
ANADA 200-081 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin methylene disalicylate
Trade Name: Sacox, 3-Nitro, BMD
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for increased rate of weight gain.
Date of Approval: March 4, 1994
ANADA 200-082 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin methylene disalicylate
Trade Name: Sacox, BMD
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(iii)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(vi)]
Date of Approval: March 18, 1994
ANADA 200-083 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bambermycins
Trade Name: Sacox, Flavomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , and for improved feed efficiency.
Date of Approval: March 18, 1994
ANADA 200-086 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), bacitracin zinc
Trade Name: Sacox, 3-Nitro, Albac
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for improved feed efficiency in broiler chickens; and for increased rate of weight gain and improved feed efficiency.
Date of Approval: March 28, 1994
ANADA 200-088 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: xylazine hydrochloride
Trade Name: Sedazine™
Indications for Use: Sedazine (xylazine) should be used in horses and Cervidaewhen it is desirable to produce a state of sedation accompanied by a shorter period of analgesia. HORSES: Sedazine has been used successfully as follows: Diagnostic procedures -- oral and opthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. Orthopedic procedures, such as application of casting materials and splints. Dental procedures. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. To calm and facilitate handling of fractious animals. Therapeutic medication for sedation and relief of pain following injury or surgery. Major surgical procedures: when used as a preanesthetic to general anesthesia; when used in conjunction with local anesthetics. CERVIDAE : Sedazine may be used for the following: To calm and facilitate the handling of fractious animals. Diagnostic procedures. Minor surgical procedures. Therapeutic medication for sedation and relief of pain following injury or surgery. As a preanesthetic to local anesthesia. Sedazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
Date of Approval: February 24, 1994
ANADA 200-089 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, bacitracin zinc
Trade Name: Sacox, Baciferm
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain.
Date of Approval: April 6, 1994
ANADA 200-090 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone (3-nitro-4-hydroxyphenylarsonic acid), lincomycin
Trade Name: Sacox, 3-Nitro, Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-091 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex/roxarsone
Trade Name: Sacox and 3-Nitro and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati , including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994
ANADA 200-092 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, virginiamycin
Trade Name: Sacox, Stafac
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain and for improved feed efficiency. [21 CFR § 558.550 (b)(1)(x)]. For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati ; and for increased rate of weight gain. [21 CFR § 558.550 (b)(1)(xi)]
Date of Approval: April 6, 1994
ANADA 200-093 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, lincomycin
Trade Name: Sacox Lincomix
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-094 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone, virginiamycin
Trade Name: Sacox 3-Nitro Stafac
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-095 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/chlortetracycline calcium complex
Trade Name: Sacox and Aureomycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti ,and E. mivati , and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: November 25, 1994
ANADA 200-096 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium/oxytetracycline
Trade Name: Sacox and Terramycin
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti , and E. mivati , and as an aid in the reduction of mortality due to airsacculitis (air sac infection) caused by Escherichia coli infections sensitive to oxytetracycline.
Date of Approval: November 25, 1994
ANADA 200-097 original approval
Sponsor: Hoechst-Roussel Agri Vet Company
Generic Name: salinomycin sodium, roxarsone
Trade Name: Sacox 3-Nitro
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for improved feed efficiency.
Date of Approval: April 6, 1994
ANADA 200-102 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: gentamicin sulfate solution
Trade Name: Gentaglyde™ Solution
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: May 19, 1994
ANADA 200-103 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: penicillin G potassium, USP
Trade Name: Penicillin G Potassium, USP
Indications for Use: For the treatment of erysipelas in turkeys caused by Erysipelothrix rhusiopathiae .
Date of Approval: October 18, 1994
ANADA 200-106 original approval
Sponsor: I.D. Russell Company
Generic Name: penicillin G potassium
Trade Name: R-Pen
Indications for Use: For treatment of erysipelas in turkeys (caused by Erysipelothrix rhusiopathiae).
Date of Approval: July 21, 1994
ANADA 200-108 original approval
Sponsor: Phoenix Pharmaceuticals, Inc.
Generic Name: Dexamethasone Solution
Trade Name: Dexamethasone Solution
Indications for Use: Treatment of primary bovine ketosis and as an anti-inflammatory agent in dogs, cats, cattle, and horses.
Date of Approval: April 13, 1995
ANADA 200-109 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: vitamin E/selenium injection
Trade Name: Velenium™ (SELENIUM, VITAMIN E)
Indications for Use: Velenium™ (SELENIUM, VITAMIN E) is recommended for the prevention and treatment of Selenium-Tocopherol Deficiency syndrome in weanling calves and breeding beef cattle.
Date of Approval: October 20, 1995
ANADA 200-113 original approval
Sponsor: The Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: June 28, 1993
ANADA 200-113 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: neomycin sulfate
Trade Name: Biosol® Liquid
Effect of Supplement: Changes withdrawal times and tolerance information.
Date of Approval: February 7, 1997
ANADA 200-115 original approval
Sponsor: Macleod Pharmaceuticals, Inc.
Generic Name: gentamicin sulfate solution
Trade Name: Gentamex™ 100
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses, and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: July 21, 1995
ANADA 200-117 original approval
Sponsor: Cross Vetpharm Group Limited
Generic Name: oxytetracycline injection
Trade Name: Oxyshot™ LA
Indications for Use: For the treatment of diseases caused by bacteria susceptible to oxytetracycline.
Date of Approval: April 13, 1995
ANADA 200-118 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: neomycin sulfate
Trade Name: Neomycin Oral Solution
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: November 29, 1994
ANADA 200-118 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Neomycin Sulfate
Trade Name: Neomycin Oral Solution
Effect of Supplement: To revise the withdrawal period to 1 day in cattle, 2 days in sheep, and 3 days for swine and goats to be identical to pioneer product.
Date of Approval: July 14, 1998
ANADA 200-122 original approval
Sponsor: Wade Jones Company
Generic Name: Penicillin G Potassium
Trade Name: Solu-Pen
Indications for Use: For the treatment of erysipelas in turkeys (casued by Erysipelothrix rhusiopathiae).
Date of Approval: April 17, 1995
ANADA 200-123 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline injection
Trade Name: Maxim 200
Indications for Use: For use in the treatment of bacterial diseases in beef cattle, nonlactating dairy cattle and swine when caused by two oxytetracycline susceptible organisms.
Date of Approval: February 10, 1995
ANADA 200-123 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline injection
Trade Name: Maxim 200
Effect of Supplement: Addition of subcutaneous route of administration for beef cattle, nonlactating dairy cattle, and preruminating (veal) calves.
Date of Approval: December 28, 2001
ANADA 200-123 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Maxim 200 Injection
Effect of Supplement: The supplement provides for use in lactating dairy cattle.
Date of Approval: November 19, 2002
ANADA 200-124 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: flunixin meglumine solution
Trade Name: Flunixin Meglumine Solution
Indications for Use: For the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Date of Approval: September 25, 1995
ANADA 200-124 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: flunixin meglumine injection
Trade Name: Flunixin Meglumine Solution
Effect of Supplement: The supplement provides revised labeling with the addition of a new species, cattle, to the previously approved generic product for horses only.
Date of Approval: November 01, 2001
ANADA 200-124 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Flunixin meglumine
Trade Name: Flunixin Meglumine Injection
Effect of Supplement: This supplement provides the addition of lactating dairy cattle to the existing claim allowing for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia. The addition of lactating dairy cattle to the pioneer labeling was approved on August 19, 2004, and was not protected by exclusivity.
Date of Approval: July 18, 2005
ANADA 200-126 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: phenylbutazone, USP
Trade Name: PHENYLBUTAZONE 20% INJECTION
Indications for Use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: September 1, 1995
ANADA 200-126 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: phenylbutazone, USP
Trade Name: Phenylbutazone 20% Injection
Effect of Supplement: This supplemental application amends the ANADA to provide for the use of Phenylbutazone 20% Injection for the relief of inflammatory conditions associated with the musculoskeletal system in dogs. Phenylbutazone 20% Injection (ANADA 200-126) is currently approved for the same indication in horses.
Date of Approval: September 6, 1996
ANADA 200-127 original approval
Sponsor: The Upjohn Company
Generic Name: spectinomycin hydrochloride (dihydrochloride pentahydrate) sterile solution
Trade Name: undetermined TRADEMARK Injectable
Indications for Use: As an aid in the control of Chronic Respiratory Disease (CRD) associated with Escherichia coli and as an aid in the control of airsacculitis associated with Mycoplasma meleagridis sensitive to spectinomycin in turkey poults. As an aid in the control of mortality and to lessen severity of infections caused by Mycoplasma synoviae, Salmonella typhimurium, Salmonella infantis, and Eschericia coli in chicks.
Date of Approval: May 9, 1996
ANADA 200-128 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Oxytetracycline dihydrate injection
Trade Name: Agrimycin®-200
Indications for Use: Beef cattle, dairy cattle, calves, including preruminating (veal) calves: indicated in the treatment of pneumonia and shipping fever complications associated with Pasteurella spp., and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infection and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
Swine: indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, it is indicated as an aid in the control of
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by
Escherichia coli.
Date of Approval: June 13, 2003
ANADA 200-129 original approval
Sponsor: Halocarbon Laboratories (Division of Halocarbon Products Corporation)
Generic Name: isoflurane, USP
Trade Name: isoflurane, USP
Indications for Use: Isoflurane, USP is used for induction and maintenance of general anesthesia in dogs and horses.
Date of Approval: June 29, 1995
ANADA 200-130 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Neomycin sulfate
Trade Name: Neo-Sol® 50
Effect of Supplement: This supplemental application provides for use in an additional species, growing turkeys.
Date of Approval: October 25, 2002
ANADA 200-134 original approval
Sponsor: Intervet Inc.
Generic Name: gonadorelin diacetate tetrahydrate injection
Trade Name: Fertagyl®
Indications for Use: Fertagyl® is indicated for the treatment of ovarian follicular cysts in dairy cattle. Ovarian cysts are non-ovulated follicles with incomplete luteinization which result in nymphomania or irregular estrus.
Historically, cystic ovaries have responded to an exogenous source of luteinizing hormone (LH) such as human chorionic gonadotropin. Fertagyl® initiates release of endogenous LH to cause ovulation and luteinization.
Date of Approval: June 17, 1996
ANADA 200-136 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: tetracycline hydrochloride-324
Trade Name: Tetracycline Hydrochloride Soluble Powder-324
Indications for Use: For use in the control and treatment of certain diseases or infections caused by bacteria susceptible to otetracycline in swine, calves, chickens, and turkeys.
Date of Approval: December 17, 1996
ANADA 200-137 original approval
Sponsor: Phoenix Pharmaceutical, Inc.
Generic Name: Gentamicin sulfate solution
Trade Name: Gentamicin Sulfate Solution
Indications for Use: For the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: November 13, 1996
ANADA 200-139 original approval
Sponsor: Chanelle Pharmaceutical Manufacturing Ltd.
Generic Name: xylazine hydrochloride
Trade Name: Chanazine® 100 mg/mL Injectable
Indications for Use: Chanazine (xylazine) should be used in horses and Cervidae when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.
Date of Approval: May 16, 1995
ANADA 200-140 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: chlortetracycline, sulfathiazole, and penicillin
Trade Name: Aureozol®
Indications for Use: For use in pre-starter, starter, grower, and finisher feeds administered in complete feed to swine raised in confinement or on limited pasture to reduce the incidence of cervical abscesses; treat bacterial swine enteritis; maintain weight gains in the presence of atrophic rhinitis; and increase rate of weight gain and improved feed efficiency.
Date of Approval: December 2, 1997
ANADA 200-141 original approval
Sponsor: Inhalon Pharmaceuticals, Inc.
Generic Name: isoflurane, USP
Trade Name: Isoflurane, USP
Indications for Use: For induction and maintenance of anesthesia in dogs and horses.
Date of Approval: July 26, 1994
ANADA 200-142 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: flunixin meglumine
Trade Name: Flunixin Meglumine Solution
Indications for Use: "Tradename" (flunixin meglumine) solution is recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in horses. It is also recommended for the alleviation of visceral pain associated with colic in horses.
Date of Approval: September 25, 1995
ANADA 200-143 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: salinomycin sodium, roxarsone , bacitracin zinc
Trade Name: Sacox, 3-Nitro, Baciferm
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati; and for increased rate of weight gain and improved feed efficiency.
Date of Approval: April 22, 1994
ANADA 200-144 supplemental approval
Sponsor: Cross Vetpharm Group Limited.
Generic Name: Oxytetracycline HCl
Trade Name: TETROXY® HCA-1772
Indications for Use: FOR THE CONTROL AND TREATMENT OF THE FOLLOWING DISEASES IN SWINE – Bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline. FOR BREEDING SWINE: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona, susceptible to oxytetracycline.
Date of Approval: APRIL 21, 2003
ANADA 200-144 original approval
Sponsor: Rhone Merieux, Canada, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Undetermined
Indications for Use: Oxytetracycline HCL soluble powder is for control of Mycoplasma synoviae, M. gallisepticum, Escherichia coli, and Pasteurella multocida in chickens and Hexamita meleagridis, Mycoplasma synoviae, transmissible eneritis, and coronaviral enteritis in turkeys; and control and treatment of Escherichia coli, Salmonella choleraesuis, Pasteurella multiocida, and Leptospira pomona in swine.
Date of Approval: June 26, 1995
ANADA 200-146 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: Oxytetracycline HCl Soluble Powder
Effect of Supplement: This supplemental application provides for the addition of the 2.26 kg (5 lb) bucket with a scoop. The scoop has also been added to the 907.2 g (2 lb) bucket. Revised labeling provides the statement warning against use in calves to be processed for veal and female dairy cattle 20 months of age or older.
Date of Approval: August 15, 1996
ANADA 200-146 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: oxytetracycline hydrochloride
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER
Indications for Use: It is for control control and treatment of a variety of infectious diseases caused by bacteria susceptible to oxytetracycline in chickens turkeys swine, cattle, and sheep.
Date of Approval: April 22, 1994
ANADA 200-147 original approval
Sponsor: Sanofi Animal Health, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin Sulfate Injection
Indications for Use: GENTAMICIN SULFATE INJECTION is indicated for use in the prevention of early motality in day-old chickens caused by Escherichia coli, Salmonella typhimurium, and Pseudomonas aeruginosa susceptible to gentamicin sulfate.
Date of Approval: April 10, 1995
ANADA 200-147 supplemental approval
Sponsor: Merial Ltd.
Generic Name: gentamicin sulfate solution
Trade Name: Genta-Ject ™
Effect of Supplement: This supplemental application provides for the addition of a new species (turkeys).
Date of Approval: October 30, 1998
ANADA 200-153 original approval
Sponsor: Rhone Merieux, Inc.
Generic Name: neomycin sulfate
Trade Name: NEO 200 Oral Solution
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle (excluding veal calves), swine, sheep, and goats.
Date of Approval: May 8, 1996
ANADA 200-154 original approval
Sponsor: Pennfield Oil Co
Generic Name: oxytetracycline injection
Trade Name: Oxytetracycline 200
Indications for Use: For use in the treatment of infectious diseases in beef cattle, nonlactating dairy cattle and swine when due to oxytetracycline susceptible organisms.
Date of Approval: May 8, 1996
ANADA 200-154 supplemental approval
Sponsor: Pennfield Oil Co
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Pennox™ 200 Injection
Effect of Supplement: The supplement provides for the addition of the subcutaneous administration of oxytetracycline injectable solution in beef cattle, non-lactating dairy cattle, and calves, including pre-ruminating (veal) calves.
Date of Approval: January 12, 2001
ANADA 200-154 supplemental approval
Sponsor: Pennfield Oil Co
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: Pennox 200 Injection
Effect of Supplement: The supplement provides for the use in lactating diary cattle.
Date of Approval: June 13, 2002
ANADA 200-162 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: tripelennamine hydrochloride
Trade Name: Tripelennamine Hydrochloride Injection
Indications for Use: For use in conditions in which antihistaminic therapy may be expected to lead to the alleviation of some signs of disease in cattle and horses.
Date of Approval: March 28, 1996
ANADA 200-164 original approval
Sponsor: Planalquimica Industrial Ltd.
Generic Name: nicarbazin, bacitracin methylene disalicylate
Trade Name: Nicarmix 25, BMD
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis in broiler chickens and for increased rate of weight gain and improved feed efficiency.
Date of Approval: November 29, 1995
ANADA 200-165 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: sulfadimethoxine 12.5% oral solution
Trade Name: SDM Sulfadimethoxine 12.5% Oral Solution
Indications for Use: For Broiler and replacement chicken: Coccidiosis, fowl cholera, and coryza; Meat producing turkey: Coccidiosis and fowl cholera; dairy calves and heifers, and beef cattle: Shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: December 4, 1996
ANADA 200-167 original approval
Sponsor: Hoffmann-La Roche Inc. (formerly American Cyanamid)
Generic Name: chlortetracycline, sulfathiazole, and penicillin
Trade Name: Aureozol® 500 Granular
Indications for Use: Administer to swine in a complete feed for reduction of the incidence of cervical abscesses; treatment of bacterial swine enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency in pigs from 10 pounds of body weight to 6 weeks post-weaning; and increased rate of weight gain in pigs from 6 to 16 weeks post-weaning. For swine raised in confinement (dry lot) or on limited pasture.
Date of Approval: December 1, 1997
ANADA 200-168 original approval
Sponsor: Equi Aid Products Inc.
Generic Name: pyrantel tartrate
Trade Name: CW 48 (Type A medicated article)
Indications for Use: For use in horses for prevention and/or control of certain strongyle, pinworm, and ascarid infections.
Date of Approval: July 24, 1997
ANADA 200-170 original approval
Sponsor: Planalquimica Industrial Ltda.
Generic Name: Nicarbazin, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid), Lincomycin hydrochloride monohydrate
Trade Name: Nicarmix 25®, 3-Nitro®, Lincomix®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix,and E. brunetti) coccidiosis and for increased rate of weight gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-171 original approval
Sponsor: Planalquimica Industrial Ltda.
Generic Name: Nicarbazin, Lincomycin hydrochloride monohydrate
Trade Name: Nicarmix 25®, Lincomix®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella ) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis and for increased rate of gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-172 original approval
Sponsor: Planalquimica Industrial Ltd.
Generic Name: Nicarbazin, Roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Nicarmix 25®, 3-Nitro®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella ) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti ) coccidiosis and for increased rate of weight gain in broiler chickens.
Date of Approval: March 5, 1996
ANADA 200-174 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: gentamicin sulfate
Trade Name: Gentamicin Sulfate Pig Pump Oral Solution
Indications for Use: For treatment of colibacillosis in neonatal pigs 1-3 days of age.
Date of Approval: April 10, 1997
ANADA 200-176 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Prazitech™ Injection
Indications for Use: For the removal of the following cestodes: Dogs - Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, and Echinococcus multilocularis. Cats - Taenia taeniaeformis and Dipylidium caninum.
Date of Approval: October 16, 2002
ANADA 200-177 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: sulfadimethoxine injection 40%
Trade Name: Sulfadimethoxine
Indications for Use: For treatment of bovine respiratory disease complex (shipping fever complex) and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; necrotic pododermatitis (foot rot) and calf diptheria caused by Fusobacterium necrophorum (Sphaerophorus necrophorus) sensitive to sulfadimethoxine.
Date of Approval: March 13, 1997
ANADA 200-178 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: amikacin sulfate, USP
Trade Name: Amikacin Sulfate Injection
Indications for Use: For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli and Proteus spp. and sking and soft tissue infections caused by susceptible strains of Pseudommonas sp. and Escherichia coli.
Date of Approval: March 14, 1997
ANADA 200-180 original approval
Sponsor: G.C. Hanford Mfg. Co.
Generic Name: Ampicillin Trihydrate
Trade Name: Ampicillin Trihydrate
Indications for Use: For the treatment of respiratory tract, urinary tract, gastrointestinal infections and skin, soft-tissue and post-surgical infection in dogs and cats. Respiratory tract infections in cattle and calves including non-ruminating (veal calves).
Date of Approval: April 24, 1998
ANADA 200-181 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: amikacin sulfate solution, 250 mg/mL
Trade Name: Amikacin Sulfate Solution
Indications for Use: For the treatment of uterine infections (endometritis, metritis, and pyometra) in mares, when caused by susceptible organisms including E. coli, Pseudomonas sp., and Klebsiella sp.
Date of Approval: March 18, 1997
ANADA 200-183 original approval
Sponsor: Med-Pharmex Inc.
Generic Name: Gentamicin sulfate and betamethasone valerate otic solution
Trade Name: Gentavet® Otic Solution
Indications for Use: Gentavet Otic Solution is indicated for the treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin.
Date of Approval: July 31, 1995
ANADA 200-184 original approval
Sponsor: Chanelle Pharmaceutical Manufacturing Ltd.
Generic Name: Xylazine hydrochloride, 20 mg/mL
Trade Name: Chanazine® 20 mg/mL
Indications for Use: Chanazine (xylazine) should be used in dogs and cats when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.
Date of Approval: July 12, 1996
ANADA 200-185 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: gentamicin sulfate soluble powder
Trade Name: Gen-gard™ Soluble Powder
Indications for Use: For the control and treatment of colibacillosis in weanling swine caused by strains of E. coli sensitive to gentamicin, and the control and treatment of swine dysentery associated with Treponema hyodysenteriae.
Date of Approval: April 30, 1997
ANADA 200-187 original approval
Sponsor: Marsam Pharmaceuticals, Inc.
Generic Name: Isoflurane, USP
Trade Name: Isoflurane, USP
Indications for Use: IsoFlo (isoflurane, USP) is used for induction and maintenance of general anesthesia in horses and dogs.
Date of Approval: February 11, 1998
ANADA 200-188 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: gentamicin sulfate and betamethasone valerate topical spray
Trade Name: Betagen™ Topical Spray
Indications for Use: For the treatment of infected superficial lesions in dogs caused by bacteria sensitive to gentamicin.
Date of Approval: January 29, 1997
ANADA 200-189 original approval
Sponsor: I.D. Russell Company Laboratories
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Soluble
Indications for Use: For treatment of dysentery (bloody scours) in swine and for the control in broiler chickens of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Date of Approval: November 7, 1997
ANADA 200-189 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: lincomycin hydrochloride
Trade Name: Lincomycin Soluble
Effect of Supplement: Removal of the withdrawal period in swine. Removal of the weight restriction in swine.
Date of Approval: September 19, 2002
ANADA 200-191 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: gentamicin sulfate
Trade Name: Gentasol (gentamicin sulfate solution)
Indications for Use: For the reduction or elimination of the following organisms from turkey hatching eggs: Arizon hinshawii (paracolon), Salmonella st. paul, Mycoplasma meleagridis.
Date of Approval: March 24, 1997
ANADA 200-192 original approval
Sponsor: Phoenix Scientific, Inc
Generic Name: sulfadimethoxine B.P.
Trade Name: Sulfadimethoxine 12.5% Oral Solution
Indications for Use: Dairy Calves, Dairy Heifers and Beef Cattle- Use for the treatment of shipping fever complex, and bacterial pneumonia associated with Pasteurella Spp. sensitive to sulfadimethoxine; and calf diptheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Date of Approval: March 24, 1997
ANADA 200-193 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: clindamycin hydrochloride, USP
Trade Name: Clindamycin hydrochloride oral liquid
Indications for Use: For therapy of wounds, abscesses, dental infections, and osteomyelitis.
Date of Approval: August 1, 1997
ANADA 200-193 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin Hydrochloride, USP
Trade Name: Clindamycin Hydrochloride Oral Liquid
Effect of Supplement: provides for the addition of feline claims to the previous approved label for use in canine only.
Date of Approval: December 27, 2000
ANADA 200-193 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Oral Liquid
Effect of Supplement: The supplement provides for approval of a dose range and revised indications for use of Clindamycin Hydrochloride Oral Liquid in dogs and cats which was approved for the pioneer product under NADA 135-940 (67 FR 54954, Aug. 27, 2002) with no exclusivity period. The expanded range was changed from a point dose of 2.5 mg/lb. in dogs to an expanded range of 2.5 to 15 mg/lb. The change in cats was from a range of 5.0 to 10.0 mg/lb. to a range of 5.0 to 15.0 mg/lb. The revised indications provides for a change in the words ‘soft tissues infections’ to ‘skin infections’ for dogs and cats.
Date of Approval: April 21, 2004
ANADA 200-196 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: miconazole nitrate lotion/spray 1%
Trade Name: Miconosol
Indications for Use: For treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
Date of Approval: August 4, 1997
ANADA 200-197 original approval
Sponsor: Contemporary Products, Inc.
Generic Name: streptomycin sulfate 25% solution
Trade Name: Streptomycin Oral Solution
Indications for Use: Chickens: For the treatment of non-specific infectious enteritis caused by organisms susceptible to streptomycin sulfate. Swine and Calves: For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella spp. susceptible to streptomycin sulfate.
Date of Approval: August 3, 1998
ANADA 200-200 original approval
Sponsor: Halocarbon Products Corporation
Generic Name: halothane, USP
Trade Name: Halothane, USP
Indications for Use: For induction and maintenance of anesthesia in dogs, cats, and other non-food animals.
Date of Approval: April 10, 1997
ANADA 200-202 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin
Trade Name: Phoenectin™ Liquid for Horses
Indications for Use: For the treatment and control of large strongyles (adult) (Strongylus equinus), (adult andarterial larval stages) (Strongylus vulgaris), (adult and migrating tissue stages)(Strongylus endentatus) (adult) (Triodontophorus spp.); small strongyles (adult and fourth stagelarvae) (Cyathostomum spp. Cylicocyclus spp., Cylicodontophorus spp.Cylicostephanus spp.); pinworms (adult and fourth stagelarvae) (Oxyuris equi); ascarids (third- and fourth-stagelarvae and adults) (Parascaris equorum); hairworms (adult) (Trichostongylusaxei); large mouth stomach worms (adult) (Habronemamuscae); stomach bots (oral and gastric stages) (Gastrophilus spp.); lungworms (adults and fourth stage larvae) (Dictyocaulusarnfieldi); intestinal threadworms (adults) (Strongyloides westeri); summer sores caused by Habronema and Draschia spp. cutaneous third stage larvae; and dermatitis caused by neck threadworm microfilariae (Onchocerca spp.).
Date of Approval: June 5, 1998
ANADA 200-203 original approval
Sponsor: Alpharma, Inc.
Generic Name: carbarsone, bacitracin zinc
Trade Name: Carb-O-Sep®, Albac®
Indications for Use: As an aid in preventing blackhead and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-204 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc
Trade Name: Bio-Cox®, Albac®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for increased rate of weight gain.
Date of Approval: Sept. 22, 1997
ANADA 200-205 original approval
Sponsor: Alpharma, Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc
Trade Name: Amprol HI-E®, Albac®
Indications for Use: (1) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur in broiler chickens and replacement chickens where immunity to coccidiosis is not desired and for increased rate of weight gain in broiler chickens raised in floor pens. (2) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur, and for improved feed efficiency in broiler chickens.
Date of Approval: Sept. 22, 1997
ANADA 200-206 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, bacitracin zinc, roxarsone
Trade Name: Deccox®; Albac®; 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-207 original approval
Sponsor: Alpharma, Inc.
Generic Name: clopidol, bacitracin zinc, roxarsone
Trade Name: Coyden 25®, Albac®, 3-Nitro®
Indications for Use: To aid in preventing coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Date of Approval: Sept. 22, 1997
ANADA 200-208 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Roxarsone, Bacitracin zinc
Trade Name: AVATEC, 3-NITRO, ALBAC
Indications for Use: 1) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the reduction of lesions due to E. tenella; and for increased rate of weight gain in broiler chickens only. 2) For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the reduction of lesions due to E. tenella; and for improved feed efficiency in broiler chickens only.
Date of Approval: June 24, 2002
ANADA 200-209 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc, roxarsone
Trade Name: Sacox®, Albac®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increases rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-210 original approval
Sponsor: Alpharma, Inc
Generic Name: salinomycin, bacitracin zinc
Trade Name: Sacox®, Albac®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and for increased rate of weight gain.
Date of Approval: Sept. 22, 1997
ANADA 200-211 original approval
Sponsor: Alpharma, Inc.
Generic Name: monensin, bacitracin zinc, roxarsone
Trade Name: Coban®, Albac®, 3-Nitro®
Indications for Use: 1) To prevent coccidiosis caused by Eimeria tenella, E. necatrix, E. acervuolina, E. brunetti, E. mivati and E. maxima and for increased rate of weight gain; 2) To prevent coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for improved feed efficiency and improved pigmentation by enhancing carotenoid and xanthophyll use.
Date of Approval: Sept. 22, 1997
ANADA 200-212 original approval
Sponsor: Alpharma, Inc.
Generic Name: robenidine hydrochloride, bacitracin zinc
Trade Name: Robenz®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by susceptible organisms; and, in the presence of 4 to 30 g/ton bacitractin zinc, for increased rate of weight gain; and, in the presence of 27 to 50 g/ton bacitracin zinc, for improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-213 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, bacitracin zinc
Trade Name: Deccox®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-214 original approval
Sponsor: ALPHARMA, Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc, roxarsone
Trade Name: Amprol HI-E®, Albac®, 3-Nitro®
Indications for Use: 1) To aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur and for improved feed efficiency in broiler chickens; 2) to aid in preventing coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur and for improved feed efficiency and improved pigmentation in broiler chickens.
Date of Approval: Sept. 22, 1997
ANADA 200-215 original approval
Sponsor: Alpharma, Inc.
Generic Name: salinomycin, bacitracin zinc, roxarsone
Trade Name: Bio-Cox®, Albac®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 22, 1997
ANADA 200-217 original approval
Sponsor: Alpharma Inc.
Generic Name: amprolium, ethopabate, bacitracin zinc, roxarsone
Trade Name: Amprol Hi-E®, Albac®, 3-Nitro®
Indications for Use: To aid in preventing coccidiosis where severe exposure from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur, and for increased rate of weight gain in broiler chickens raised in floor pens.
Date of Approval: September 22, 1997
ANADA 200-218 original approval
Sponsor: Alpharma, Inc.
Generic Name: clopidol, bacitracin zinc
Trade Name: Coyden 25®, Albac®
Indications for Use: To aid in preventing coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati and E. brunetti and for increased rate of weight gain and improved feed efficiency.
Date of Approval: Sept. 22, 1997
ANADA 200-219 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Phoenectin™ Pour-On for Cattle
Indications for Use: For the control of the following parasites: gastrointestinal roundworms (Ostertagia ostertagi, adult and fourth stage larvae including inhibited stage; Haemonchus placei, adults and fourth stage larvae; Trichostrongylus axei, adults and fourth stage larvae; T. colubriformis, adults and fourth stage larvae; Cooperia spp., adults and fourth stage larvae; Strongyloides papillosus, adults; Oesophagostomum radiatum, adults and fourth stage larvae; O. venulosum, adults only; Trichuris spp., adults: lungworms (Dictyocaulus viviparus, adults and fourth stage larvae); cattle grubs (Hypoderma bovis, H. lineatum, parasitic stages); mites (Sarcoptes scabei var. bovis, Chorioptes bovis); lice (Linognathus vituli, Haematopinus eurysternus, Damalina bovis, Solenoptes capillatus); and horn flies (Haematobia irritans).
Date of Approval: July 6, 1998
ANADA 200-219 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Phoenectin™ Pour-On for Cattle
Indications for Use: Ivermectin Pour-On applied at the recommended dose level of 500mcg/kg is indicated for the effective control and treatment of these parasites: Gastrointestinal Roundworms: Ostertagia ostertagi (adults and L4) (including inhibited stage), Haemonchus placei (adults and L4), Trichostrongylus axei (adults and L4), T. colubriformis (adults and L4), Cooperia spp. adults and L4), Strongyloides papillosus (adults), Oesophagostomum radiatum (adults and L4), Trichuris spp. (adults). Lungworms: Dictyocaulus viviparus (adults and L4). Cattle Grubs: (parasitic stages): Hypoderma bovis, H. lineatum. Mites: Sarcoptes scabiei var. bovis. Lice: Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenopotes capillatus. Horn Flies: Haematobia irritants. Phoenectin™ Pour-On has been proved to effectively control infections and to protect cattle from re-infection with Ostertagia ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: May 16, 2001
ANADA 200-221 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate and estradiol
Trade Name: Component™ TE-S
Indications for Use: For increased rate of weight gain and improved feed efficiency in feedlot steers.
Date of Approval: March 20, 1997
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate, estradiol, and Tylosin Tartrate
Trade Name: Component®TE-S with Tylan®
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-S with Tylan®
Date of Approval: July 20, 1999
ANADA 200-221 original approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: Component® TE-G
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, and feeder steers and heifers).
Date of Approval: March 6, 2000
ANADA 200-221 supplemental approval
Sponsor: Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate, Estradiol, and Tylosin Tartrate
Trade Name: Component® TE-G with Tylan®
Effect of Supplement: This supplement provides for adding tylosin tartrate pellet as a local antibacterial to Component® TE-G
Date of Approval: September 18, 2000
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: Component® TE-G
Indications for Use: The supplement provides for the use of a generic copy of Intervet, Inc.’s REVALOR-IS, a 4-pellet ear implant containing 80 mg trenbolone acetate and 16 mg estradiol.
Date of Approval: September 3, 2003
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Inc., Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate, estradiol, tylosin tartrate
Trade Name: Component® TE-IS with Tylan®
Indications for Use: For increased rate of weight gain and improved feed efficiency. The supplement provides for the use of a generic copy of Intervet, Inc.’s REVALOR-IS, a 4-pellet ear implant containing 80 mg trenbolone acetate and 16 mg estradiol.
Date of Approval: February 13, 2004
ANADA 200-221 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-S, COMPONENT TE-IS, COMPONENT TE-G, COMPONENT TE-S with TYLAN, COMPONENT TE-IS with TYLAN, COMPONENT TE-G with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004
ANADA 200-223 original approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin zinc
Trade Name: Albac®50
Indications for Use: For improved feed efficiency in growing-finishing feedlot steers; For increased rate of weight gain and improved feed efficiency in growing-finishing feedlot heifers.
Date of Approval: August 20, 1997
ANADA 200-224 original approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate
Trade Name: Component™ T-S; Component™T-H
Indications for Use: For improved feed efficiency in growing-finishing feedlot steers; for increased rate of weight gain and improved feed efficiency in growing-finishing feedlot heifers.
Date of Approval: April 30, 1997
ANADA 200-224 supplemental approval
Sponsor: Ivy Laboratories, Inc.
Generic Name: trenbolone acetate and Tylosin Tartrate
Trade Name: 1) Component® T-S with Tylan® 2) Component®T-H with Tylan®
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® T-S and Component® T-H
Date of Approval: July 20, 1999
ANADA 200-224 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Trenbolone Acetate, Trenbolone Acetate with Tylosin
Trade Name: COMPONENT T-H, COMPONENT T-S, COMPONENT T-H with TYLAN, and COMPONENT T-S with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 22, 2004
ANADA 200-225 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Levamisole hydrochloride
Trade Name: Prohibit™ Soluble Drench Powder
Indications for Use: As an Anthelmintic effective against stomach worms (Haemonchus, Trichostrongylus, Ostertagia), Intestinal Worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum) (Chabertia, sheep only), Lung worms (Dictyocaulus) in cattle and sheep.
Date of Approval: August 27, 1998
ANADA 200-226 original approval
Sponsor: Western Chemical, Inc.
Generic Name: tricaine methanesulfonate
Trade Name: Tricaine-S
Indications for Use: For the temporary immobilization of fish, amphibians, and other aquatic, cold-blooded anmials.
Date of Approval: November 21, 1997
ANADA 200-228 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Injectable Solution
Trade Name: Phoenectin™ Injection for Cattle and Swine
Indications for Use: Cattle: PhoenectinTM Injection is indicated in for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice and mange mites in cattle. Swine: PhoenectinTM Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine. Special Minor Use: Reindeer: For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under Administration.
American Bison: For the treatment and control of grubs (Hypoderma bovis) in American bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under Administration.
Date of Approval: December 27, 2000
ANADA 200-229 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Gentamicin Sulfate, Betamethasone Valerate and Clotrimazole Ointment
Trade Name: Tri-Otic Ointment
Indications for Use: Tri-Otic Ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Date of Approval: April 4, 1998
ANADA 200-229 supplemental approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Gentamicin sulfate, USP, betamethasone valerate, USP, and clotrimazole, USP
Trade Name: TRI-OTIC
Effect of Supplement: The addition of a 15 gram bottle package size made from a new material MDPE, instead of the existing LDPE or HDPE used in other sizes.
Date of Approval: February 27, 2006
ANADA 200-230 original approval
Sponsor: Phoenix Scientific Inc.
Generic Name: Guaifenesin Injection
Trade Name: Guaifenesin Injection
Indications for Use: For intravenous use as a skeletal muscle relaxant for horses.
Date of Approval: April 8, 1998
ANADA 200-232 original approval
Sponsor: Pliva, d.d.
Generic Name: Oxytetracycline
Trade Name: Geomycin 200
Indications for Use: Cattle: For the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infection and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. Swine: For the treatment of the bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
Date of Approval: February 12, 1999
ANADA 200-232 supplemental approval
Sponsor: PLIVA d. d.
Generic Name: Oxytetracycline Hydrochloride, USP
Trade Name: GEOMYCIN 200 Injection
Effect of Supplement: The supplement provides for the addition of the subcutaneous administration of oxytetracycline injectable solution in cattle and for the use in lactating dairy cattle.
Date of Approval: April 8, 2002
ANADA 200-233 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lincomycin Hydrochloride Soluble Powder 40 %
Trade Name: Linco Soluble
Indications for Use: For the treatment and control of swine dysentery (bloody scours) in swine under 250 pounds and for the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin in broiler chickens. Tolerance: 21CFR 556.360: Lincomycin: The ADI for total residues if lincomycin is 25 micrograms per kilogram of body weight per day. A tolerance for residues of lincomycin in chickens is not required. A tolerance of 0.6 ppm in liver and 0.1 ppm in muscle are established in swine .
Date of Approval: September 22, 1999
ANADA 200-234 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: tetracycline HCL soluble powder
Trade Name: Tetrasol soluble powder
Indications for Use: For the control of certain infections caused by organisms sensitive to tetracycline hydrochloride.
Date of Approval: July 22, 1997
ANADA 200-235 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: neomycin sulfate soluble powder
Trade Name: Neosol Soluble Powder
Indications for Use: For treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: March 9, 1998
ANADA 200-236 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: chlortetracycline HCl soluble powder
Trade Name: chlortetracycline HCl soluble powder
Indications for Use: For the control and treatment of bacterial enteritis (scours) and bacterial pneumonia caused by certain organisms in swine; for the control of infectious synovitis, chronic respiratory disease, and air sac infection caused by certain organisms in chickens; and for the control of infectious synovitis caused by certain organisms and complicating bacterial organisms associated with bluecomb in turkeys.
Date of Approval: Sept. 24, 1997
ANADA 200-237 original approval
Sponsor: Rhone-Poulenc Chemicals Ltd.
Generic Name: isoflurane, USP
Trade Name: Isoflurane, USP
Indications for Use: For induction and maintenance of surgical anesthesia in horses and dogs.
Date of Approval: December 19, 1997
ANADA 200-238 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Sulfadimethoxine
Trade Name: Sulfasol® Soluble Powder
Indications for Use: For Broiler and Replacement Chickens Only – Use for the treatment of disease outbreaks of coccidiosis, fowl cholera and infectious coryza. For Meat Producing Turkeys Only – Use for the treatment of disease outbreaks of coccidiosis and fowl cholera. For Dairy Calves, Dairy Heifers and Beef Cattle – Use for the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Date of Approval: July 28, 1998
ANADA 200-239 original approval
Sponsor: Intervet, Inc.
Generic Name: Butorphanol tartrate
Trade Name: Delorex®
Indications for Use: For the relief of pain associated with colic in adult horses and yearlings and postpartum pain in mares.
Date of Approval: September 28, 1998
ANADA 200-241 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Lincomycin Hydrochloride Soluble Powder
Trade Name: Lincosol Soluble Powder
Indications for Use: Swine: For the treatment of swine dysentery (bloody scours).
Broiler chickens: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Tolerance: 21CFR 556.360: 0.6 ppm for parent lincomycin (marker residue) in the liver (target tissue) of swine and 0.1 ppm for parent lincomycin in muscle. The Acceptable Daily Intake (ADI) is established at 0.025 mg/kg of body weight/day.
Date of Approval: February 4, 1999
ANADA 200-242 original approval
Sponsor: Hoffmann-La Roche Inc.
Generic Name: Chlortetracycline, Bacitracin Methylene Disalicylate
Trade Name: BMD®-25, BMD®-30, BMD®-40, BMD®-50, BMD®-60 or BMD®-75; and Aureomycin® -50, -70, -80, -90 or -100.
Indications for Use: For increased rate of weight gain and improved feed efficiency
Date of Approval: January 16, 1998
ANADA 200-244 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: trimethoprim/sulfadiazine powder
Trade Name: Tucoprim® Powder
Indications for Use: For control of bacterial infections of horses during treatment of acute strangles, respiratory tract infections, acute urogenital infections, wound infections, and abscesses.
Date of Approval: October 22, 1999
ANADA 200-245 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Nystatin, neomycin sulfate, thiostrepton and triamcinolone acetonide cream.
Trade Name: Derma-Vet Cream
Indications for Use: Derma-Vet Cream is indicated in the management of dermatologic disorders in dogs and cats, characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis, contact dermatitis and seborrheic dermatitis; and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: June 7, 1999
ANADA 200-246 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate usp
Trade Name: Anthelban V
Indications for Use: For the removal and control of matureinfections of large strongyles (Strongylus vulgaris, S.edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascarisequorum); and small strongyles in horses and ponies.
Date of Approval: June 18, 1998
ANADA 200-246 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate
Trade Name: Pyrantel Pamoate Equine Anthelmintic Suspension
Indications for Use: For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum); and small strongyles in horses and ponies.
Date of Approval: August 19, 2003
ANADA 200-247 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytetracycline HCL Soluble Powder-343
Indications for Use: Chickens: For the control and treatment of infectious synovitis caused by Mycoplasma synoviae; chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida.
Turkeys: For the control and treatment of hexamitiasis caused by Hexamita meleagridis; infectious synovitis caused by Mycoplasma synoviae; and control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).
Cattle: For the treatment and control in calves, beef cattle and nonlactating dairy cattle of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
Swine: For the control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, bacterial pneumonia caused by Pasteurella multocida; and reducing the incidence of abortions and shedding of leptospira in breeding swine caused by Leptospira pomona.
Sheep: For the treatment and control of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
Date of Approval: February 10, 1999
ANADA 200-247 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER-343
Indications for Use: OXYTETRACYCLINE HCL SOLUBLE POWDER – 343 is indicated for a variety of bacterial infections in cattle, sheep, swine, chickens, turkeys, and honeybees associated with organisms susceptible to oxytetracycline.
CALVES, BEEF CATTLE AND NON-LACTATING DAIRY CATTLE: Control and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
SHEEP: Control and treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia (shipping fever complex) caused by Pasteurella multocida.
SWINE: Control and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida. For Breeding Swine: Leptospirosis (reducing the incidence of abortions and shedding of leptospira) caused by Leptospira pomona.
CHICKENS: Control of infectious synovitis caused by Mycoplasma synoviae, chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli, and fowl cholera caused by Pasteurella multocida.
TURKEYS: Control of hexamitiasis caused by Hexamita meleagridis and infectious synovitis caused by Mycoplasma synoviae. Growing turkeys-complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).
HONEYBEES: Control and treatment of American and European foulbrood caused by Bacillus larvae.
Date of Approval: November 12, 2003
ANADA 200-247 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Oxytetracycline HCl
Trade Name: OXYTETRACYCLINE HCL SOLUBLE POWDER-343
Effect of Supplement: This supplemental applicaiton provides for the additional use in a new species, finfish fry and fingerlings, for skeletal marking by immersion as an aid in identification.
Date of Approval: September 15, 2004
ANADA 200-248 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel Pamoate USP
Trade Name: Pyrantel Pamoate Suspension - 4.54mg, Pyrantel Pamoate Suspension - 2.27mg
Indications for Use: To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping. For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. The presence of these parasites should be confirmed by laboratory fecal examination.
Date of Approval: July 16, 1998
ANADA 200-251 original approval
Sponsor: Med Pharmex, Inc.
Generic Name: Sulfadimethoxine
Trade Name: Sulforal®
Indications for Use: Broiler and Replacement Chickens: For the treatment of coccidiosis, fowl cholera and infectious coryza-concentration: 0.05% 1 fl. oz to 2 gallons of drinking water. Meat-Producing Turkeys:For the treatment of coccidiosis and fowl cholera-concentration: 0.025% 1 fl. oz to 4 gallons of drinking water. Dairy Calves, Dairy Heifers and Beef Cattle: For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria and foot rot-dosage: 25 mg/lb first day followed by 12.5 mg/lb for 4 days (as drinking water or drench)
Date of Approval: August 3, 1998
ANADA 200-253 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Dinoprost tromethamine
Trade Name: ProsaMate™ Sterile Solution
Indications for Use: For estrus synchronization, treatment of unobserved (silent) estrus and pyometra (chronic endometritis) in cattle; for abortion of feedlot and other non-lactating cattle; for parturition in swine; and for controlling the timing of estrus in estrous cycling mares and clinically anestrous mares that have a corpus luteum.
Date of Approval: February 12, 1999
ANADA 200-254 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: iron Hydrogenated Dextran
Trade Name: iron Dextran Injection (100 mg/mL)
Indications for Use: For the prevention or treatment of iron deficiency anemia in baby pigs
Date of Approval: July 14, 1998
ANADA 200-256 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: iron Dextran Complex
Trade Name: iron Dextran Injection-200
Indications for Use: For the prevention or treatment of anemia due to iron deficiency
Date of Approval: August 17, 1998
ANADA 200-257 original approval
Sponsor: Vetrepharm Research, Inc.
Generic Name: Ketamine hydrochloride injection USP
Trade Name: Ketamine HCl
Indications for Use: Used in cats for restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. Used in subhuman primates for restraint.
Date of Approval: November 09, 2001
ANADA 200-258 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Sulfadimethoxine Soluble Powder
Trade Name: Sulfadimethoxine Soluble Powder
Indications for Use: Chickens: For the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza. Turkeys: For the treatment of disease outbreaks of coccidiosis and fowl cholera. Cattle: For the treatment of shipping fever complex and bacterial pneumonia associated with Pasteurella spp. sensitive to sulfadimethoxine; and calf diphtheria and foot rot associated with Sphaerophorus necrophorus sensitive to sulfadimethoxine.
Date of Approval: March 4, 1999
ANADA 200-259 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium, roxarsone
Trade Name: ChlorMax™, Sacox®, 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998
ANADA 200-260 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium, roxarsone
Trade Name: ChlorMax™, Bio-Cox®, 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998
ANADA 200-261 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium
Trade Name: ChlorMax™/ Bio-Cox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998
ANADA 200-262 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, salinomycin sodium
Trade Name: ChlorMax™/Sacox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatments.
Date of Approval: September 21, 1998
ANADA 200-263 original approval
Sponsor: Alpharma, Inc.
Generic Name: Chlortetracycline, monesin sodium
Trade Name: ChlorMax™/Coban®
Indications for Use: As an aid in the reduction of mortality due to E. coli infections susceptible to such treatmentsand in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.
Date of Approval: September 21, 1998
ANADA 200-265 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Praziquantel Tablets
Indications for Use: For the removal of Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus and for the removal and control of Echinococcus multilocularis.
Date of Approval: August 28, 2003
ANADA 200-265 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Praziquantel
Trade Name: Prazi-C Tablets
Effect of Supplement: This supplement provides for OTC marketing of Prazi-C (praziquantel) Tablets in 5, 10, and 50-tablet container sizes.
Date of Approval: September 15, 2004
ANADA 200-266 original approval
Sponsor: Bioniche Animal Health, Inc.
Generic Name: Phenylbutazone Paste
Trade Name: Butequine ®
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: February 21, 2003
ANADA 200-270 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin Tablets
Trade Name: Iverhart
Indications for Use: Iverhart is indicated for the prevention of canine heartworm (Dirofilaria immitis) disease
Date of Approval: November 30, 2001
ANADA 200-271 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Levamisole Phosphate
Trade Name: Levamisole phosphate
Indications for Use: For treatment in cattle excluding dairy animals of breeding age with the following nematode infections: STOMACH WORMS: (Haemonchus, Ostertagia, Trichostrongylus) INTESTINAL WORMS: (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia)
Date of Approval: September 7, 2000
ANADA 200-272 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: Noromectin® Pour-On for Cattle
Indications for Use: NOROMECTIN (ivermectin) Pour-On for Cattle when applied at the recommended dose of 500 mcg/kg is indicated for the effective control and treatment of gastrointestinal roundworms (including Ostertagia ostertagi) lungworms, grubs, hornflies, sucking and biting lice, and sarcoptic mange mites in cattle.
Date of Approval: September 13, 2004
ANADA 200-272 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN
Effect of Supplement: The effect of the supplement is to add claims that are no longer protected by three years marketing exclusivity that expired on November 24, 2006, specifically: Dictyocaulus viviparus for 28 days, Cooperia surnabada for 14 days, and Damalinia bovis for 56 days after treatment. Also, the persistent activity periods are extended for the following: Oesophagostomum radiatum from 14 days to 28 days and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment.
Date of Approval: January 19, 2007
ANADA 200-273
Sponsor: Altana, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Vetro-Gen™ Veterinary Ophthalmic Ointment
Indications for Use: For treatment of conjunctivitis caused by susceptible bacteria.
Date of Approval: June 8, 2004
ANADA 200-274 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lincomycin HCL
Trade Name: Lincomycin Injectable 30%
Indications for Use: For the treatment of infectious arthritis and mycoplasmal pneumonia.
Date of Approval: February 1, 2002
ANADA 200-275 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Triamcinolone Acetonide Cream
Trade Name: Medalone Cream
Indications for Use: Medalone Cream (Triamcinolone Acetonide Cream) is indicated for topical treatment of allergic dermatitis and summer eczema in dogs.
Date of Approval: February 4, 2000
ANADA 200-279 original approval
Sponsor: Abbott Laboratories
Generic Name: Ketamine Hydrochloride Injection
Trade Name: KetaFlo™
Indications for Use: For restraint or as the sole anesthetic agent for diagnostic or minor, brief, surgical procedures that do not require skeletal muscle relaxation. It may be used in subhuman primates for restraint.
Date of Approval: June 13, 2000
ANADA 200-280 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Pentobarbital sodium and phenytoin sodium
Trade Name: Euthanasia-III Solution
Indications for Use: For use in dogs for humane, painless, and rapid euthanasia.
Date of Approval: February 3, 2005
ANADA 200-281 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Flavored Pyrantel Pamoate Tablets
Trade Name: To be determined
Indications for Use: For the removal of large roundworms (ascarids) (Toxocara canis; Toxascaris leonina) and hookworms (Ancylostoma caninum; Uncinaria stenocephala) in dogs and puppies. To prevent reinfection of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
Date of Approval: January 3, 2001
ANADA 200-282 original approval
Sponsor: Farnam Companies, Inc
Generic Name: Pyrantel tartrate
Trade Name: Continuex™
Indications for Use: For the prevention of Strongylus vulgaris larval infestation in horses and for control of the following parasites. Large strongyles (adults): S. vulgaris, S. edentatus; Small strongyles (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., Triodontophorus spp.; Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and fourth-stage larvae): Parascaris equorum.
Date of Approval: September 26, 2000
ANADA 200-283 original approval
Sponsor: Altana Inc.
Generic Name: Gentamicin sulfate, USP, betamethasone valerate, USP, and clotrimazole, USP
Trade Name: VETRO-MAX
Indications for Use: For the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Date of Approval: June 1, 2006
ANADA 200-286 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Ivermectin Paste 1.87%
Trade Name: PhoenectinTM (ivermectin) Paste 1.87%
Indications for Use: For treatment and control of the parasites or parasitic conditions. Large strongyles (adults): S. vulgaris (and arterial larval stages), S. edentatus (and tissue stages), S. equinus, Triodontophorus spp.; Small strongyles (adults and fourth-stage larvae) including those resistant to some benzimidizole class compounds: Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.; Pinworms (adults and fourth-stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large-mouth Stomach Worms (adults): Habronema muscae; Bots (oral and gastric stages): Gastrophilus spp.; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca spp.
Date of Approval: September 20, 2000
ANADA 200-287 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Gentamicin Sulfate, Betamethasone Valerate and Clotrimazole Ointment
Trade Name: GBC Ointment™
Indications for Use: Treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin
Date of Approval: March 28, 2003
ANADA 200-287 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP
Trade Name: TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate, USP; and clotrimazole, USP Ointment)
Effect of Supplement: This supplement provides for an additional package size, 20-gram fill in a 30 mL bottle. The bottle will be the same LDPE as the approved 15 mL bottle, and the plug, dropper and cap will be the exact same closure as the approved package.
Date of Approval: January 21, 2005
ANADA 200-287 supplemental approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Gentamicin sulfate, betamethasone valerate, clotrimazole
Trade Name: TripleMax™
Effect of Supplement: This application provides for a new container size (40 gram dropper bottle).
Date of Approval: August 23, 2006
ANADA 200-289 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: neomycin sulfate
Trade Name: Neoral Oral Solution
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate.
Date of Approval: July 3, 2000
ANADA 200-291 original approval
Sponsor: Delmarva Laboratories, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clinsol®
Indications for Use: For the treatment of infections caused by susceptible strains of the designated microorganism in the specific conditions listed for Dogs and Cats.
Date of Approval: August 26, 2002
ANADA 200-292 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: Iversol Liquid for Horses
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
Date of Approval: December 7, 2000
ANADA 200-293 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Furosemide Injection 5 %
Trade Name: Furosemide Injection 5 %
Indications for Use: Diuretic-saluretic for prompt relief of edema.
Date of Approval: December 18, 2001
ANADA 200-295 original approval
Sponsor: PennField Oil Company
Generic Name: chlortetracycline HCL powder
Trade Name: Pennchlor™ 64
Indications for Use: Calves (not veal), beef cattle and nonlactating dairy cattle and swine:
Control of bacterial pneumonia (Pasteurella spp., Hemophilus spp., Klebsiella spp.) and bacterial enteritis (Escherichia coli, Salmonella spp.).Turkeys:Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis or Coronavirus enteritis) susceptible to chlortetracycline. Also for the control of infectious synovitis (Mycoplasma synoviae).Chickens:Control of chronic respiratory disease (CRD) and air-sac infection (Mycoplasma gallisepticum, Escherichia coli). Also for the control of mortality due to fowl cholera (Pasteurella multocia) in growing chickens.
Date of Approval: April 27, 2001
ANADA 200-298 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin Hydrochloride Capsules
Trade Name: Clindamycin Hydrochloride Capsules
Indications for Use: For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval.
Date of Approval: June 14, 2002
ANADA 200-298 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Capsules
Effect of Supplement: For the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Date of Approval: April 21, 2004
ANADA 200-299 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Ivermectin Pour-On for Cattle
Indications for Use: For the effective control and treatment of these parasites in cattle: Gastrointestinal Roundworms; Lungworms; Cattle Grubs; Mites; Lice; Horn Flies It is also used to control infections of gastrointestinal roundworms: O. ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: December 28, 2000
ANADA 200-299 supplemental approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: IVER-ON
Effect of Supplement: The effect of the supplement is the addition of CVM requested changes to the Environmental Safety, Disposal statement, and Residue Information portions of the labeling and the addition of claims that are no longer protected by three years marketing exclusivity that expired on November 24, 2006, specifically: Dictyocaulus viviparus for 28 days, Cooperia surnabada for 14 days, and Damalinia bovis for 56 days after treatment. Also, the persistent activity periods are extended for the following: Oesophagostomum radiatum from 14 days to 28 days and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment.
Date of Approval: May 7, 2007
ANADA 200-301 original approval
Sponsor: First Priority, Inc.
Generic Name: Chlorhexidine Antiseptic Ointment
Trade Name: Privasan™ Antiseptic Ointment
Indications for Use: Privasan™ Antiseptic Ointment is used as a topical antiseptic ointment for surface wounds on dogs, cats, and horses.
Date of Approval: November 6, 2001
ANADA 200-302 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin and Pyrantel (as pamoate salt)
Trade Name: Iverhart™ Plus Flavored Chewables
Indications for Use: For the prevention of canine heartworm (Dirofilaria immitis) disease and for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala, and Ancylostoma braziliense in dogs over 6 weeks of age.
Date of Approval: May 30, 2001
ANADA 200-303 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin Hydrochloride Soluble Powder
Trade Name: Lincomycin Hydrochloride Soluble Powder
Indications for Use: For treatment of swine and broiler chickens
Date of Approval: October 1, 2002
ANADA 200-304 original approval
Sponsor: First Priority, Inc.
Generic Name: Copper naphthenate solution
Trade Name: Pritox™
Indications for Use: FAs an aid in treating horses and ponies with thrush due to organisms susceptible to copper naphthenate.
Date of Approval: July 25, 2003
ANADA 200-305 original approval
Sponsor: Vétoquinol N.-A., Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: Oxytetracycline hydrochloride soluble powder
Indications for Use: For the treatment of bacterial diseases in chickens, turkeys, and swine.
Date of Approval: June 2, 2006
ANADA 200-306 original approval
Sponsor: Norbrook Laboratories, Inc.
Generic Name: Oxytetracycline injection
Trade Name: Oxytetracycline Injection 200 mg/mL
Indications for Use: Cattle: For the treatment of pneumonia and shipping fever complex...
Swine: For the treatment of the bacterial enteritis...
Date of Approval: June 18, 2002
ANADA 200-307 original approval
Sponsor: Vétoquinol N.-A., Inc.
Generic Name: Penicillin G potassium
Trade Name: Penicillin G Potassium, USP
Indications for Use: For the treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
Date of Approval: January 29, 2004
ANADA 200-308 original approval
Sponsor: Norbrook Laboratories Ltd
Generic Name: Flunixin meglumine
Trade Name: Flunixin Injection (50 mg/mL)
Indications for Use: It is indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders in the ANADA 200-308 horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse. In cattle, it is indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Injection is also indicated for control of inflammation in endotoxemia.
Date of Approval: November 17, 2003
ANADA 200-308 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Flunixin meglumine
Trade Name: Flunixin Injectable
Effect of Supplement: This supplement provides for the addition of use in lactating dairy cattle for the control of pyrexia associated with bovine respiratory disease and endotoxemia and for the control of inflammation in endotoxemia.
Date of Approval: March 1, 2006
ANADA 200-312 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Dexamethasone
Trade Name: DEXIUM
Indications for Use: For treatment of primary bovine ketosis and as an anti-inflammatory agent in the canine, feline, bovine and equine.
Date of Approval: October 20, 2003
ANADA 200-313 original approval
Sponsor: Phoenix Scientific, Inc
Generic Name: Levamisole hydrochloride
Trade Name: Levamisole Hydrochloride Soluble Pig Wormer
Indications for Use: For the treatment effective against nematode infections.
Date of Approval: October 25, 2002
ANADA 200-314 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline calcium complex and sulfamethazine
Trade Name: PENNCHLOR S 700™
Indications for Use: As an aid in the maintenance of weight gains in the presence of respiratory disease such as shipping fever.
Date of Approval: January 29, 2003
ANADA 200-315 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Lincomycin hydrochloride monohydrate
Trade Name: Lincomycin 25, Lincomycin 100, Lincomycin 300
Indications for Use: For the treatment of infectious arthritis and mycoplasma pneumonia.
Date of Approval: April 2, 2003
ANADA 200-316 original approval
Sponsor: Delmarva Laboratories, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clintabs®
Indications for Use: For treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed in the approval
Date of Approval: June 6, 2002
ANADA 200-317 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Dexamethasone sodium phosphate
Trade Name: Dexium-SP™
Indications for Use: For use as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.
Date of Approval: April 29, 2004
ANADA 200-318 original approval
Sponsor: Virbac AH, Inc..
Generic Name: Ivermectin Topical Liquid
Trade Name: Virbamec™ Pour-On for Cattle
Indications for Use: For the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi), lungworms, grubs, horn flies, sucking and biting lice, chorioptic and sarcoptic mange mites. Treatment for horn flies for 28 days. It is also use to control infections of gastrointestinal roundworms: O. ostertagi, O. radiatum, H. placei, T. axei, Cooperia punctata, and C. oncophora for 14 days after treatment.
Date of Approval: September 21, 2001
ANADA 200-318 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin
Trade Name: VIRBAMEC Pour-on for Cattle
Effect of Supplement: The effect of the supplement is the addition of a new 10 L package size; and revised labeling that includes updated (a) speciation of Cooperia, (b) Environmental Safety information, (c) Mode of Action information, (d) Residue Information, and (e) Indications section.
Date of Approval: July 6, 2007
ANADA 200-319 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Acepromazine Maleate Injection
Trade Name: Acepromazine Maleate Injection
Indications for Use: Dogs and Cats: Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. Acepromazine Maleate Injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine Maleate Injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.
Date of Approval: March 25, 2003
ANADA 200-320 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin Paste
Trade Name: Equell™ (ivermectin) Paste
Indications for Use: For the treatment and control of parasitic conditions.
Date of Approval: August 9, 2002
ANADA 200-320 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin
Trade Name: EQUELL
Effect of Supplement: The effect of the supplement is to incorporate CVM requested changes to the label’s “WARNING” and “INDICATIONS” sections and to add expired three-year exclusivity claims
Date of Approval: October 24, 2006
ANADA 200-321 original approval
Sponsor: First Priority, Inc
Generic Name: Ivermectin Liquid for Horses
Trade Name: Primectin™ Equine Oral Liquid
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, large-mouth stomach worms, bots, lungworms, summer sores and cutaneous onchocerciasis.
Date of Approval: September 7, 2001
ANADA 200-322 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Butorphanol Tartrate, USP
Trade Name: Butorphanol Tartrate Injection
Indications for Use: Butorphanol Tartrate Injection is indicated for the relief of pain associated with colic in adult horses and yearlings.
Date of Approval: January 22, 2003
ANADA 200-323 original approval
Sponsor: West-Ward Pharmaceutical Corp.
Generic Name: Phenylbutazone Tablets
Trade Name: Phenylbutazone Tablets USP, 1 gram
Indications for Use: For relief of inflammatory conditions associated
with the musculoskeletal system in horses.
Date of Approval: March 28, 2003
ANADA 200-324 original approval
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Dexamethasone Injection
Trade Name: Dexamethasone Injection 2 mg/mL
Indications for Use: Treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses.
Date of Approval: August 19, 2003
ANADA 200-326 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: BIMECTIN Paste 1.87%
Indications for Use: BIMECTIN Paste 1.87% provides effective treatment and control of the following parasites in horses: Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S .edentatus (also tissue stages), S. equinus; Triodontophorus spp. including T. brevicauda and T. serratus; Small Strongyles (adults, including those resistant to some benzimidizole class compounds) – Cyathostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Small Stronglyes – Fourth-stage larvae; Pinworms (adults and fourthstage larvae) – Oxyuris equi; Ascarids (adults, thirdstage and fourth-stage larvae) Parascaris equorum;
Hairworms (adults):
Trichostrongylus axei; Large-mouth Stomach Worms (adults) – Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stages larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Date of Approval: January 19, 2005
ANADA 200-326 supplemental approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Ivermectin
Trade Name: BIMECTIN Paste 1.87%
Effect of Supplement: This supplement provides for new indications for use claims no longer protected by a three-year exclusivity period that expired on April 2, 2006:
Large Strongyles – Craterostomum acuticaudatum;
Small Strongyles – Petrovinema poculatum and Coronocyclus spp. including C. coronatus, and C. labratus.
The generic labeling includes an additional indication for use claim for a parasite species not protected by exclusivity, C. labiatus.
This supplement also provides for revised packaging and minor label revisions.
Date of Approval: May 23, 2008
ANADA 200-327 original approval
Sponsor: First Priority, Inc.
Generic Name: Ivermectin liquid
Trade Name: Privermectin™ Drench for Sheep
Indications for Use: Treatment and control of gastrointestinal roundworms, lungworms, and nasal bots.
Date of Approval: May 15, 2002
ANADA 200-330 original approval
Sponsor: Altana Inc..
Generic Name: Nystatin, neomycin sulfate, thiostrepton, and triamcinolone acetonide
Trade Name: ANIMAX Cream
Indications for Use: Topical dermatologic disorders
characterized by inflammation and dry or exudative dermatitis, particularly associated with bacterial or candidal infections.
Date of Approval: September 4, 2003
ANADA 200-332 original approval
Sponsor: Lloyd, Inc.
Generic Name: Butorphanol tartrate
Trade Name: BUTORPHIC Injection
Indications for Use: Butorphic Injection is indicated for relief of pain associated with colic in adult horses and yearlings. Clinical studies in the horse have shown that Butorphic Injection alleviates abdominal pain associated with torsion, impaction, intussusception, and tympanic colic, and postpartum pain.
Date of Approval: May 1, 2008
ANADA 200-333 original approval
Sponsor: Superior Equine Pharmaceuticals, Inc.
Generic Name: Phenylbutazone
Trade Name: SUPERIORBUTE
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: April 20, 2007
ANADA 200-334 original approval
Sponsor: A & G Pharmaceuticals, Inc.
Generic Name: Phenylbutazone
Trade Name: EQUIZONE 100
Indications for Use: For the relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: November 18, 2005
ANADA 200-338 original approval
Sponsor: Heska Corporation
Generic Name: Ivermectin/Pyrantel
Trade Name: TRI-HEART Plus (ivermectin/pyrantel) Chewable Tablets
Indications for Use: Prevents heartworm disease by eliminating the tissue stage of heartworm (Dirofilaria immitis) larvae for a month after infection and for the treatment and control of ascarids (Toxocara canis, Toxascaris leonina) and hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense).
Date of Approval: August 13, 2003
ANADA 200-340 original approval
Sponsor: First Priority, Inc.
Generic Name: Ivermectin Topical Liquid
Trade Name: Privermectin ™ Pour-On for Cattle
Indications for Use: Treatment and control of gastrointestinal roundworms, lungworms, mites, cattle grubs, lice, and horn flies.
Date of Approval: December 4, 2002
ANADA 200-341
Sponsor: Veterinary Laboratories, Inc.
Generic Name: Ivermectin
Trade Name: SparMectin-E
Indications for Use: For the treatment and control of large strongyles, small strongyles, hairworms, pinworms, roundworms (ascarids), intestinal threadworms, largemouth stomach worms, bots, lungworms and summer sores. Also treats cutaneous onchocerciasis.
Date of Approval: March 8, 2004
ANADA 200-342 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate paste
Trade Name: Pyrantel Pamoate Paste
Indications for Use: For the removal and control of mature infections of the following parasites: Large strongyles:Strongylus vulgaris, S. edentatus, S. equinus: Small strongyles; Pinworms: Oxyuris equi; Large roundworms; Parascaris equorum
Date of Approval: January 22, 2003
ANADA 200-342 supplemental approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Pyrantel pamoate
Trade Name: Pyrantel Pamoate Paste
Effect of Supplement: The supplement to NADA 200-342 provides revisions to 21 CFR 520.2044: Addition of label claim for the removal and control of mature infections of tapeworms (Anoplocephala perfoliata) in horses and ponies, with a single oral
dose of 6 milligrams pyrantel base per pound of body weight. The sponsor conducted effectiveness and target animal safety studies in support of this label claim; thus, this supplemental application is a submission under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act. As a result, the application status of this supplemental approval for Pyrantel Pamoate Paste is designated NADA 200-342.
Date of Approval: April 18, 2005
ANADA 200-343 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate
Trade Name: Heifermax™ 500
Indications for Use: For heifers fed in confinement for slaughter – for increased weight gain, improved feed efficiency, and suppression of estrus (heat). For heifers intended for breeding – for suppression of estrus (heat).
Date of Approval: December 3, 2004
ANADA 200-344 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Tiamulin hydrogen fumarate
Trade Name: Tiamulin Soluble Antibiotic
Indications for Use: For the treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: February 16, 2005
ANADA 200-345 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin hydrochloride monohydrate, spectinomycin dihydrochloride pentahydrate
Trade Name: Lincomycin - Spectinomycin
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of air sacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and Complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
Date of Approval: February 5, 2004
ANADA 200-346 original approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-H
Indications for Use: For Increased rate of weight gain and improved feed efficiency for heifers fed in confinement for slaughter.
Date of Approval: September 27,2002
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-H with Tylan
Effect of Supplement: This supplement provides for the addition of a tylosin tartrate pellet as a local antibacterial to Component® TE-H.
Date of Approval: April 18, 2003
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component® TE-IH
Effect of Supplement: This submission for Component® TE-IH for heifers is a supplement to the original ANADA 200-346 for Component® TE-H. Component® TE-IH is a lower dose of Component® TE-H with each pellet in Component® TE-IH (total of 4 pellets) containing 20 mg trenbolone acetate and 2 mg estradiol in the same formulation as each pellet in Component® TE-H (total of 7 pellets).
Date of Approval: August 19, 2003
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories,Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Component ® TE-200
Effect of Supplement: Component® TE-200 for steers is a supplement to the original ANADA 200-346 for Component® TE-H. Component® TE-200 is a higher dose of Component® TEH, with each pellet in Component® TE-200 (a total of 10 pellets) containing 20 mg trenbolone acetate and 2 mg estradiol in the same formulation as each pellet in Component® TE-H (total of 7 pellets).
Date of Approval: April 21, 2003
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate and estradiol, and tylosin tartrate
Trade Name: COMPONENT TE-IH with Tylan®
Indications for Use: For increased rate of weight gain.
Date of Approval: February 23, 2004
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-200 with TYLAN®
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-H, COMPONENT TE-IH, COMPONENT TE-H with TYLAN, and COMPONENT TE-IH with TYLAN
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories, Division of Ivy Animal Health, Inc.
Generic Name: Trenbolone acetate and estradiol
Trade Name: COMPONENT TE-200
Effect of Supplement: This supplement provides for the addition of heifers to the label of Ivy Laboratories’ approved product COMPONENT TE-200 (trenbolone acetate and estradiol). The indications are for increased rate of weight gain and improved feed efficiency in steers and heifers fed in confinement for slaughter.
Date of Approval: January 14, 2005
ANADA 200-346 supplemental approval
Sponsor: Ivy Laboratories
Generic Name: Trenbolone Acetate and Estradiol with Tylosin
Trade Name: COMPONENT TE-200 with TYLAN
Effect of Supplement: This supplement provides for the addition of a 29 mg tylosin tartrate pellet as a local antibacterial to COMPONENT TE-200 for use in steers and heifers fed in confinement for slaughter.
Date of Approval: January 26, 2007
ANADA 200-347 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Penicillin G Potassium USP Soluble Powder
Trade Name: Penicillin G Potassium USP Soluble Powder
Indications for Use: Penicillin G Potassium Soluble Powder is indicated in turkeys for the treatment of erysipelas caused by Erysipelothrix rhusiopathiae.
Date of Approval: January 22, 2003
ANADA 200-348 original approval
Sponsor: ECO LLC
Generic Name: Ivermectin Topical Liquid
Trade Name: Ivermectin
Indications for Use: For treatment of gastrointestinal roundworms, lungworms, cattle grubs, mites, lice, and horn flies.
Date of Approval: November 15, 2002
ANADA 200-350 original approval
Sponsor: Cross Vetpharm Group Limited
Generic Name: Pyrantel Pamoate Oral Paste
Trade Name: Exodus™ (pyrantel pamoate) Paste
Indications for Use: Pyrantel pamoate paste is indicated for the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); small strongyles; pinworms (Oxyuris equi); and large roundworms (Parascaris equorum) in horses and ponies.
Date of Approval: March 25, 2003
ANADA 200-351 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Lincomycin Hydrochloride monohydrate
Trade Name: Lincomycin Injectable, USP
Indications for Use: For the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides such as Staphylococci, Streptococci, Erysipelothrix and Mycoplasma spp. It is also indicated for the treatment of mycoplasma pneumonia.
Date of Approval: February 13, 2004
ANADA 200-352 original approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Canine-2X and PRIMEX Canine
Indications for Use: For the removal of large roundworms (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) in dogs and puppies. To prevent reinfestation of Toxocara canis in puppies and adult dogs and in lactating bitches after whelping.
Date of Approval: August 20, 2003
ANADA 200-353 original approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Equine
Indications for Use: For the removal and control of mature large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pin worms (Oxyuris equi); large roundworms (Parascaris equorum) and small strongyles in horses and ponies.
Date of Approval: August 19, 2003
ANADA 200-354 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline, Monesin sodium
Trade Name: Pennchlor™ (Pennfield Oil Co.), Coban®(Elanco Animal Health, Inc.)
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: August 15, 2003
ANADA 200-355 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline
Trade Name: Pennchlor™, Bio-Cox, 3-Nitro
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone, and as an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline.
Date of Approval: March 31, 2003
ANADA 200-356 original approval
Sponsor: Pennfield Oil Co.
Generic Name: Chlortetracycline hydrochloride, tiamulin hydrogen fumarate
Trade Name: Pennchlor™ & Denagard®
Indications for Use: For treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline, and control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin.
Date of Approval: April 06, 2004
ANADA 200-357 original approval
Sponsor: Pennfield Oil Company
Generic Name: Chlortetracycline, Salinomycin sodium
Trade Name: Pennchlor. (Pennfield Oil Co.), Bio-Cox® (Alpharma, Inc)
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: August 19, 2003
ANADA 200-358 original approval
Sponsor: Pennfield Oil Co.
Generic Name: Chlortetracycline hydrochloride, bacitracin methylene disalicylate
Trade Name: Pennfield Oil Co.
Indications for Use: For increased rate of weight gain and improved feed efficiency; for treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Date of Approval: July 2, 2004
ANADA 200-359 original approval
Sponsor: Pennfield Oil Compnay
Generic Name: Chlortetracycline, decoquinate
Trade Name: Pennchlor™ / Deccox®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: March 19, 2004
ANADA 200-360 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Tiamulin hydrogen fumarate
Trade Name: Tiamulin Liquid Concentrate
Indications for Use: For the treatment of swine dysentery associated with Brachyspira hyodysenteriae and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: June 24, 2005
ANADA 200-361 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Acepromazine maleate
Trade Name: Acepromazine Maleate Injection
Indications for Use: Dogs and Cats: Acepromazine Maleate Injection can be used as an aid in controlling intractable animals during examination, treatment, grooming, x-ray and minor surgical procedures; to alleviate itching as a result of skin irritation; as an antiemetic to control vomiting associated with motion sickness. Acepromazine Maleate Injection is particularly useful as a preanesthetic agent (1) to enhance and prolong the effects of barbiturates, thus reducing the requirements for general anesthesia; (2) as an adjunct to surgery under local anesthesia. Horses: Acepromazine Maleate Injection can be used as an aid in controlling fractious animals during examination, treatment, loading and transportation. Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery and applying casts.
Date of Approval: April 14, 2004
ANADA 200-362 original approval
Sponsor: First Priority, Inc.
Generic Name: Miconazole nitrate
Trade Name: PRICONAZOLE Lotion, 1%; PRICONAZOLE Spray, 1%
Indications for Use: PRICONAZOLE (miconazole nitrate) Lotion, 1% and Spray, 1% are indicated for the treatment of fungal infections in dogs and cats caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
Date of Approval: November 14, 2005
ANADA 200-364 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Spectinomycin dihydrochloride pentahydrate
Trade Name: SYNOVEX
Indications for Use: For the treatment and control of porcine enteric colibacillosis (scours) caused by E. coli susceptible to spectinomycin
Date of Approval: July 29, 2004
ANADA 200-365 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Glycopyrrolate, USP
Trade Name: Glycopyrrolate Injectable 0.2 mg/mL
Indications for Use: As a preanesthetic anticholinergic agent in dogs and cats
Date of Approval: October 2, 2006
ANADA 200-366 original approval
Sponsor: IMPAX Laboratories, Inc.
Generic Name: Carprofen
Trade Name: Carprofen Caplets
Indications for Use: For the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: April 27, 2005
ANADA 200-366 supplemental approval
Sponsor: Impax Laboratories, Inc.
Generic Name: Carprofen
Trade Name: Novox® Caplets
Effect of Supplement: This application provides for the additional indication for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
Date of Approval: July 27, 2006
ANADA 200-367 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Trenbolone acetate and estradiol
Trade Name: SYNOVEX T40; SYNOVEX T80; SYNOVEX T120
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004
ANADA 200-368 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride
Trade Name: LincoMed™ 100, LincoMed™ 300
Indications for Use: For the treatment of infectious forms of arthritis caused by organisms sensitive to its activity. This includes most of the organisms responsible for the various infectious arthritides in swine, such as, staphylococci, streptococci, Erysipelothrix and Mycoplasma spp. It is also indicated for the treatment of mycoplasma pneumonia.
Date of Approval: August 2, 2006
ANADA 200-371 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Phenylbutazone
Trade Name: Phenylbutazone 20% Injection
Indications for Use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: July 8, 2005
ANADA 200-373 original approval
Sponsor: First Priority, Inc.
Generic Name: Furosemide
Trade Name: Furosemide Syrup 1%
Indications for Use: A diuretic-saluretic for oral use alone or in combination with Furosemide Injection in the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
Date of Approval: November 18, 2005
ANADA 200-374 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Tetracycline hydrochloride
Trade Name: TETRAMED 324 HCA
Indications for Use: For use in the control and treatment of the following conditions in swine, calves, and poultry.
SWINE AND CALVES:
Use for the control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Actinobacillus pleuropneumoniae, Pasteurella spp., and Klebsiella spp. sensitive to tetracycline hydrochloride.
CHICKENS:
Use for the control of chronic respiratory disease (CRD) and air sac infection caused by Mycoplasma gallisepticum and Escherichia coli; infectious synovitis caused by Mycoplasma synoviae sensitive to tetracycline hydrochloride.
TURKEYS:
Use for the control of infectious synovitis caused by Mycoplasma synoviae and bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms susceptible to tetracycline hydrochloride.
Date of Approval: September 13, 2005
ANADA 200-375 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, monensin sodium, tylosin phosphate
Trade Name: HEIFERMAX 500, RUMENSIN, TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat), reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes, and the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in heifers being fed in confinement for slaughter.
Date of Approval: September 19, 2005
ANADA 200-376 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Sodium sulfadimethoxine
Trade Name: SULFAMED-G Soluble Powder
Indications for Use: For Broiler and Replacement Chickens Only: Use for the treatment of disease outbreaks of coccidiosis, fowl cholera, and infectious coryza.
For Meat-producing Turkeys Only: Use for the treatment of disease outbreaks of coccidiosis and fowl cholera.
For Dairy Calves, Dairy Heifers, and Beef Cattle: Use for the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot rot.
Date of Approval: November 14, 2005
ANADA 200-377 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride
Trade Name: Lincomed Soluble Powder
Indications for Use: Swine: For the treatment of swine dysentery (bloody scours). Broiler chickens: For the control of necrotic enteritis caused by Clostridium perfringens susceptible to lincomycin.
Date of Approval: December 6, 2004
ANADA 200-378 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Neomycin sulfate
Trade Name: Neomycin Sulfate 325
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate. For the control of mortality associated with Escherichia coli organisms susceptible to neomycin sulfate in growing turkeys.
Date of Approval: August 31, 2006
ANADA 200-379 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Neomycin sulfate
Trade Name: NEOMYCIN Liquid
Indications for Use: For the treatment and control of colibacillosis (bacterial enteritis) caused by Escherichia coli susceptible to neomycin sulfate in cattle, swine, sheep, and goats.
Date of Approval: October 24, 2006
ANADA 200-380 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Lincomycin hydrochloride monohydrate and spectinomycin dihydrochloride pentahydrate
Trade Name: SPECLINX-50
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of: Airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and complicated Chronic Respiratory Disease (Air Sac Infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycinspectinomycin.
Date of Approval: June 7, 2005
ANADA 200-382 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Furosemide
Trade Name: Furosemide Syrup 1%
Indications for Use: A diuretic-saluretic for oral use alone or in combination with furosemide Injection in the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.
Date of Approval: November 18, 2004
ANADA 200-383 original approval
Sponsor: Novopharm Ltd.
Generic Name: Clindamycin hydrochloride
Trade Name: CLINDAROBE Capsules
Indications for Use: CLINDAROBE Capsules is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase-positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius). Deep wounds and abscesses due to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens. Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens.
Date of Approval: December 19, 2007
ANADA 200-386 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: Levamisole hydrochloride
Trade Name: Levamisole Hydrochloride Soluble Drench Powder
Indications for Use: Levamisole hydrochloride is a broad spectrum anthelmintic and is effective against the following adult nematode infections in cattle and sheep: Sheep: Stomach Worms: Haemonchus contortus, Trichostrongylus axei, Teladorsagia circumcincta. Intestinal Worms: Trichostrongylus colubriformis, Cooperia curticei, Nematodirus spathiger, Bunostomum trigonocephalum, Oesophagostomum columbianum, Chabertia ovina Lungworms: Dictyocaulus filariaCattle: Stomach Worms: Haemonchus placei, Ostertagia ostertagi, Trichostrongylus axei Intestinal Worms: Trichostrongylus longispicularis, Cooperia oncophora, Cooperia punctata, Nematodirus spathiger, Bunostomum phlebotomum, Oesophagostomum radiatum Lungworms: Dictyocaulus viviparus
Date of Approval: December 17, 2004
ANADA 200-387 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Flunixin meglumine
Trade Name: FLUNAZINE
Indications for Use: Horse: recommended for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse. It is also recommended for the alleviation of visceral pain associated with colic in the horse.
Cattle: indicated for the control of pyrexia associated with bovine respiratory disease and endotoxemia. Flunixin Meglumine Injection is also indicated for the control of inflammation in endotoxemia.
Date of Approval: March 2, 2006
ANADA 200-389 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Amprolium
Trade Name: Amprolium 9.6% Oral Solution
Indications for Use: As an aid in the treatment and prevention of coccidiosis caused by Eimeria bovis and E. zurnii.
Date of Approval: September 6, 2006
ANADA 200-390 original approval
Sponsor: Med-Pharmex, Inc.
Generic Name: Ivermectin
Trade Name: Ivermectin Paste 1.87%
Indications for Use: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Ivermectin Paste provides effective treatment and control of the following parasites in horses. Large Strongyles (adults) – Strongylus vulgaris (also early forms in blood vessels), S .edentatus (also tissue stages), S. equinus; Triodontophorus spp. including T. Brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidizole class compounds) – Coronocyclus spp. including C. coronatus, C. labiatus and C. labratus; Cyanthostomum spp. including C. catinatum and C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus and C. brevicapsulatus; Cylicodontophorus spp.; Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus and C. minutus, and Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) – Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) – Parascaris equorum; Hairworms (adults) – Trichostrongylus axei; Large-mouth Stomach Worms (adults) –
Habronema muscae; Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) – Dictyocaulus arnfieldi; Intestinal Threadworms (adults) – Strongyloides westeri;
Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae;
Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Date of Approval: June 20, 2006
ANADA 200-391 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Griseofulvin
Trade Name: Griseofulvin Powder Microsize
Indications for Use: Equine – Ringworm infection caused by Trichophyton equinum or Microsporum gypseum.
Date of Approval: June 1, 2006
ANADA 200-394 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin Piglet Injection
Indications for Use: For the treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin
Date of Approval: November 17, 2006
ANADA 200-395 original approval
Sponsor: Sparhawk Laboratories, Inc.
Generic Name: Gentamicin sulfate
Trade Name: Gentamicin sulfate solution
Indications for Use: Recommended for the control of bacterial infections of the uterus (metritis) in horses and as an aid in improving conceptions in mares with uterine infections caused by bacteria sensitive to gentamicin.
Date of Approval: July 31, 2006
ANADA 200-398 original approval
Sponsor: First Priority, Inc.
Generic Name: Clindamycin hydrochloride
Trade Name: Clindamycin Hydrochloride Oral Drops
Indications for Use: Clindamycin Hydrochloride Oral Drops (for use in dogs and cats) is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:
Dogs: Skin infections (wounds and abscesses) due to coagulase positive staphylococci (Staphylococcus aureus or Staphyloccus intermedius). Deep wounds and abscesses due
to Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens. Dental infections due to S. auerus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens. Osteomyelitis due to S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.
Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius and Streptococcus spp. Deep wounds and infections due to Clostridium perfringens and Bacteroides fragilis. Dental infections due to S. aureus, S. intermedius, Streptococcus spp., C. perfringens, and B. fragilis.
Date of Approval: March 19, 2007
ANADA 200-407 original approval
Sponsor: Agri Laboratories, Ltd.
Generic Name: Lincomycin hydrochloride/spectinomycin dihydrochloride pentahydrate
Trade Name: Lincomycin-Spectinomycin Water Soluble Powder
Indications for Use: For use in chickens up to 7 days of age as an aid in the control of airsacculitis caused by either Mycoplasma synoviae or Mycoplasma gallisepticum susceptible to lincomycin-spectinomycin and complicated chronic respiratory disease (air sac infection) caused by Escherichia coli and M. gallisepticum susceptible to lincomycin-spectinomycin.
Date of Approval: November 9, 2006
ANADA 200-408 original approval
Sponsor: IVX Animal Health, Inc.
Generic Name: Butorphanol tartrate
Trade Name: Butorphanol Tartrate Injection (2mg/mL)
Indications for Use: Indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Date of Approval: April 20, 2007
ANADA 200-415 original approval
Sponsor: First Priority, Inc.
Generic Name: Gentamicin sulfate, betamethasone valerate
Trade Name: Gentamicin Sulfate Topical Spray
Indications for Use: For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.
Date of Approval: January 12, 2007
ANADA 200-418 original approval
Sponsor: Altana Inc.
Generic Name: Mupirocin
Trade Name: MURICIN Ointment 2%
Indications for Use: MURICIN Ointment 2% is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.
Date of Approval: March 8, 2007
ANADA 200-422 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, monensin sodium
Trade Name: HEIFERMAX 500, RUMENSIN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in heifers being fed in confinement for slaughter.
Date of Approval: March 22, 2006
ANADA 200-424 original approval
Sponsor: Ivy Laboratories, Div. of Ivy Animal Health, Inc.
Generic Name: Melengestrol acetate, ractopamine hydrochloride, monensin sodium, and tylosin phosphate
Trade Name: HEIFERMAX 500, OPTAFLEXX, RUMENSIN, and TYLAN
Indications for Use: For suppression of estrus (heat), increased rate of weight gain, improved feed efficiency, increased leanness, the prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: April 27, 2006
ANADA 200-427 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, tylosin phosphate
Trade Name: HEIFERMAX 500, TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter.
Date of Approval: April 19, 2006
ANADA 200-430 original approval
Sponsor: Ivy Laboratories,
Generic Name: Melengestrol acetate, lasalocid sodium, tylosin phosphate
Trade Name: HEIFERMAX 500, BOVATEC, TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, suppression of estrus (heat) and reduced incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in heifers being fed in confinement for slaughter.
Date of Approval: June 1, 2006
ANADA 200-434 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Sodium sulfamethazine
Trade Name: SMZ-MED 454 Soluble Powder
Indications for Use: For treatment and control of disease caused by organisms sensitive to sulfamethazine: Beef and nonlactating dairy cattle: Treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) (Pasteurella spp.), colibacillosis (bacterial scours)(Escherichia coli), necrotic pododermatitis (foot rot)(Fusobacterium necrophorum), calf diphtheria (Fusobacterium necrophorum), acute mastitis (Streptococcus spp.), and acute metritis (Streptococcus spp.). Swine: Treatment of porcine colibacillosis (bacterial scours) (Escherichia coli), and bacterial pneumonia (Pasteurella spp.). Chickens and turkeys. In chickens for control of infectious coryza (Haemophilus gallinarum), coccidiosis (Eimeria tenella, Eimeria necatrix), acute fowl cholera (Pasteurella multocida), and pullorum disease (Salmonella pullorum). In turkeys for control of coccidiosis (Eimeria meleagrimitis, Eimeria adenoeides).
Date of Approval: November 3, 2006
ANADA 200-435 original approval
Sponsor: Modern Veterinary Therapeutics, LLC
Generic Name: Doxapram hydrochloride
Trade Name: RESPIRAM
Indications for Use: For dogs, cats and horses: To stimulate respirations during and after general anesthesia. To speed awakening and return of reflexes after anesthesia. For neonate dogs and cats: Initiate respirations following cesarean section or dystocia. To stimulate respirations following dystocia or cesarean section.
Date of Approval: November 21, 2006
ANADA 200-436 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin and Clorsulon
Trade Name: NOROMECTIN Plus Injection for Cattle
Indications for Use: NOROMECTIN Plus Injection for Cattle is indicated for the effective treatment and control of the following parasites in cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Oesophagostomum radiatum
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Liver Flukes:
Fasciola hepatica (adults only)
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mange Mites (cattle scab):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis
Persistent Activity
Ivermectin and clorsulon injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment; Ostertagia ostertagi, Trichostrongylus axei, Cooperia punctata for 21 days after treatment; Haemonchus placei and Cooperia oncophora for 14 days after treatment.
Date of Approval: April 23, 2007
ANADA 200-437 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN Injection for Cattle and Swine
Indications for Use: Cattle: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, grubs, sucking lice, and mange mites in cattle:
Gastrointestinal Roundworms (adults and fourth-stage larvae):
Ostertagia ostertagi (including inhibited O. ostertagi)
O. lyrata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata
C. pectinata
Oesophagostomum radiatum
Bunostomum phlebotomum
Nematodirus helvetianus (adults only)
N. spathiger (adults only)
Lungworms (adults and fourth-stage larvae):
Dictyocaulus viviparus
Cattle Grubs (parasitic stages):
Hypoderma bovis
H. lineatum
Sucking Lice:
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Mites (scabies):
Psoroptes ovis (syn. P. communis var. bovis)
Sarcoptes scabiei var. bovis
Persistent Activity
Ivermectin injection has been proved to effectively control infections and to protect cattle from reinfection with Dictyocaulus viviparus for 28 days after treatment; Ostertagia ostertagi for 21 days after treatment; Oesophagostomum radiatum, Haemonchus placei, Trichostrongylus axei, Cooperia punctata and Cooperia oncophora for 14 days after treatment.
Swine: NOROMECTIN Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, lice, and mange mites in swine:
Gastrointestinal Roundworms:
Large roundworm, Ascaris suum
(adults and fourth-stage larvae)
Red stomach worm, Hyostrongylus rubidus
(adults and fourth-stage larvae)
Nodular worm, Oesophagostomum spp.
(adults and fourth-stage larvae)
Threadworm, Strongyloides ransomi (adults)
Somatic Roundworm Larvae:
Threadworm, Strongyloides ransomi (somatic larvae). Sows must be treated at least seven days before farrowing to prevent infection in piglets.
Lungworms:
Metastrongylus spp.(adults)
Lice:
Haematopinus suis
Mange mites:
Sarcoptes scabiei var. suis
Special Minor Use:
NOROMECTIN Injection is indicated for the effective treatment and control of warbles (Oedemagena tarandi) in reindeer. Follow use directions for cattle as described under Administration
NOROMECTIN Injection is indicated for the effective treatment and control of grubs (Hypoderma bovis) in American bison. Follow use directions for cattle as described under Administration.
Date of Approval: April 20, 2007
ANADA 200-437 supplemental approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Ivermectin
Trade Name: NOROMECTIN Injection for Cattle and Swine
Effect of Supplement: This supplement provides for extension of persistent effect indications as claimed by thepioneer sponsor. Specifically, the package insert has been revised as follows: Persistent activity against Oesophagostomum radiatumchanged from 14 to 28 days and that of Trichostrongylus axei and Cooperia punctatafrom 14 to 21 days.
Date of Approval: October 5, 2007
ANADA 200-445 supplemental approval
Sponsor: First Priority, Inc.
Generic Name: Pyrantel pamoate
Trade Name: PRIMEX Equine Liquid Wormer
Effect of Supplement: For the removal and control of mature infections of large strongyles (Strongylus vulgaris, S. edentatus, S. equinus); pinworms (Oxyuris equi); large roundworms (Parascaris equorum) and small strongyles in horses and ponies.
Date of Approval: November 3, 2006
ANADA 200-448 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate, ractopamine hydrochloride, and monensin sodium
Trade Name: HEIFERMAX 500, OPTAFLEXX, and RUMENSIN
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: January 29, 2007
ANADA 200-451 original approval
Sponsor: Ivy Laboratories
Generic Name: Melengestrol acetate and lasalocid sodium
Trade Name: HEIFERMAX 500 and BOVATEC
Indications for Use: For increased rate of weight gain, improved feed efficiency, and suppression of estrus (heat) in heifers fed in confinement for slaughter.
Date of Approval: March 12, 2007
ANADA 200-452 original approval
Sponsor: Norbrook Laboratories, Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OXYTET 10 Injection
Indications for Use: The use of OXYTET 10 Injection is indicated in beef cattle, beef calves, non-lactating dairy cattle and dairy calves for the treatment of the following disease conditions caused by one or more of the oxytetracycline sensitive pathogens listed as follows Bacterial Pneumonia and Shipping Fever Complex associated with Pasteurella spp.; Bacterial Enteritis (scours) caused by Escherichia coli; Necrotic Pododermatitis (Foot Rot) and Calf Diphtheria caused by Fusobacterium necrophorum; Wooden Tongue caused by Actinobacillus lignieresii; and Wound Infections, Acute Metritis and Traumatic Injury caused by susceptible strains of streptococcusand staphylococcus organisms.
Date of Approval: June 27, 2007
ANADA 200-460 original approval
Sponsor: Cross Vetpharm Group Ltd.
Generic Name: Oxytetracycline hydrochloride
Trade Name: TETROXY Aquatic
Indications for Use: To mark skeletal tissues, most often the otoliths, of all finfish fry and fingerlings for subsequent identification.
Date of Approval: April 20, 2007
ANADA Public Master File (PMF) 5118
Sponsor: IR-4 project
Generic Name: fenbendazole
Trade Name: PANACUR
Indications for Use: For the removal and control of Haemonchus contortus and Ostertagia circumcincta in goats.
Date of Approval: April 25, 1994
