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Drug and Device Approvals-June 1996
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-597 XALATAN PHARMACIA AND UPJOHN LATANOPROST
05-JUN-96 (SOLUTION/DROPS) COLUMBUS, OH 0.005%
(1 P) 43216 (PROSTAGLANDIN ANALOGUE)
[REDUCTION OF ELEVATED
INTRAOCULAR PRESSURE IN
PATIENTS WITH OPEN-ANGLE
GLAUCOMA AND OCULAR
HYPERTENSION WHO ARE
INTOLERANT OF OTHER
INTRAOCULAR PRESSURE
LOWERING MEDICATIONS OR
INSUFFICIENTLY RESPONSIVE
(FAILED TO ACHIEVE TARGET
IOP DETERMINED AFTER
MULTIPLE MEASUREMENTS
OVER TIME) TO ANOTHER
INTRAOCULAR PRESSURE
LOWERING MEDICATION]
20-219 LIVOSTIN CIBA VISION LEVOCABASTINE
10-JUN-96 (SUSPENSION/DROPS) DULUTH, GA HYDROCHLORIDE
(SUPPL-003) 30155 EQ 0.05% BASE
(NEW DOSAGE REGIMEN --
REMOVAL OF THE CURRENT
TWO WEEK DOSING LIMITATION)
20-588 RISPERDAL JANSSEN RISPERIDONE
10-JUN-96 (SOLUTION) TITUSVILLE, NJ 1MG/ML
(3 S) 08560 (ANTIPSYCHOTIC)
[MANAGEMENT OF THE
MANIFESTATIONS OF
PSYCHOTIC DISORDERS]
20-602 JUNIOR STRENGTH MCNEIL CONS PRODS IBUPROFEN
10-JUN-96 MOTRIN FORT WASHINGTON, PA 100MG
(6 S) (TABLET) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[TEMPORARY RELIEF OF
MINOR ACHES AND PAINS
AND THE REDUCTION OF
FEVER IN CHILDREN
6 YEARS OF AGE AND OLDER]
[OTC]
20-603 CHILDREN'S MOTRIN MCNEIL CONS PRODS IBUPROFEN
10-JUN-96 (SUSPENSION/DROPS) FORT WASHINGTON, PA 40MG/ML
(3 S) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[TEMPORARY RELIEF OF
MINOR ACHES AND PAINS
AND THE REDUCTION OF
FEVER IN CHILDREN
2 YEARS OF AGE AND OLDER]
[OTC]
20-666 ALBENZA SMITHKLINE BEECHAM ALBENDAZOLE
11-JUN-96 (TABLET) PHILADELPHIA, PA 200MG
(1 P, V*) 19101 (ANTHELMINTHIC)
[TREATMENT OF
NEUROCYSTICERCOSIS AND
HYDATID DISEASE]
50-730 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
12-JUN-96 (TABLET) GROTON, CT EQ 600MG BASE
(3 P) 06340 (ANTIBIOTIC, MACROLIDE)
[PROPHYLAXIS OF
DISSEMINATED
MYCOBACTERIUM AVIUM
COMPLEX (MAC) INFECTIONS
IN HIV-INFECTED PATIENTS OR
TREATMENT OF PATIENTS WITH
MILD TO MODERATE INFECTIONS
CAUSED BY SUSCEPTIBLE
STRAINS OF MICROORGANISMS]
V* - Designated Orphan Drug
19-787 NORVASC PFIZER CEN RES AMLODIPINE BESYLATE
14-JUN-96 (TABLET) GROTON, CT EQ 2.5MG BASE
(SUPPL-007) 06340 EQ 5MG BASE
EQ 10MG BASE
(PATIENT POPULATION
ALTERED --
ADDITIONAL SAFETY DATA
REGARDING THE USE OF
NORVASC IN PATIENTS WITH
HEART FAILURE)
20-075 LIORESAL MEDTRONIC BACLOFEN
14-JUN-96 (INJECTABLE) MINNEAPOLIS, MN 0.5MG/ML
(SUPPL-004) 55432 2MG/ML
(NEW INDICATION --
MANAGEMENT OF
SEVERE SPASTICITY
[ENCOMPASSES SPINAL
AND CEREBRAL ORIGIN])
20-415 REMERON ORGANON MIRTAZAPINE
14-JUN-96 (TABLET) WEST ORANGE, NJ 15MG
(1 S) 07052 30MG
(ANTIDEPRESSANT)
[TREATMENT OF DEPRESSION]
20-563 HUMALOG LILLY INSULIN LISPRO
14-JUN-96 (INJECTABLE) INDIANAPOLIS, IN 100 UNITS/ML
(1 S) 46285 (BLOOD GLUCOSE REGULATOR)
[TREATMENT OF DIABETES
MELLITUS IN PATIENTS
REQUIRING INSULIN]
20-571 CAMPTOSAR PHARMACIA AND UPJOHN IRINOTECAN HYDROCHLORIDE
14-JUN-96 (INJECTABLE) KALAMAZOO, MI 20MG/ML
(1 P) 49001 (ANTINEOPLASTIC)
[TREATMENT OF PATIENTS WITH
METASTATIC CARCINOMA OF
THE COLON OR RECTUM WHOSE
DISEASE HAS PROGRESSED
FOLLOWING 5-FU-BASED
THERAPY]
18-723 DEPAKOTE ABBOTT DIVALPROEX SODIUM
20-JUN-96 (TABLET, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
(SUPPL-020) DELAYED RELEASE) 60064 EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
(NEW INDICATION --
TREATMENT OF PATIENTS WITH
COMPLEX PARTIAL SEIZURES
WITH AND WITHOUT SECONDARY
GENERALIZATION)
19-680 DEPAKOTE ABBOTT DIVALPROEX SODIUM
20-JUN-96 (CAPSULE, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
(SUPPL-008) DELAYED RELEASE 60064 (NEW INDICATION --
PELLETS) TREATMENT OF PATIENTS WITH
COMPLEX PARTIAL SEIZURES
WITH AND WITHOUT SECONDARY
GENERALIZATION)
18-554 EULEXIN SCHERING FLUTAMIDE
21-JUN-96 (CAPSULE) KENILWORTH, NJ 125MG
(SUPPL-014) 07033 (NEW INDICATION --
MANAGEMENT OF LOCALLY
CONFINED STAGE B2-C
METASTIC CARCINOMA
OF THE PROSTATE [IN
COMBINATION WITH LHRH
AGONISTS])
20-636 VIRAMUNE BOEHRINGER INGELHEIM NEVIRAPINE
21-JUN-96 (TABLET) RIDGEFIELD, CT 200MG
(1 P) 06877 (ANTIVIRAL)
[INDICATED IN COMBINATION
WITH NUCLEOSIDE ANALOGUES
FOR THE TREATMENT OF HIV-1
INFECTED ADULTS WHO HAVE
EXPERIENCED CLINICAL
AND/OR IMMUNOLOGIC
DETERIORATION]
50-706 MERREM I.V. ZENECA MEROPENEM
21-JUN-96 (INJECTABLE) WILMINGTON, DE 500MG BASE/VIAL
(1 S) 19897 1GM BASE/VIAL
(ANTIBIOTIC, CARBAPENEM)
[ADULT/PEDIATRIC -
COMPLICATED INTRA-
ABDOMINAL INFECTIONS;
PEDIATRIC - BACTERIAL
MENINGITIS]
20-199 HIVID ROCHE ZALCITABINE
26-JUN-96 (TABLET) NUTLEY, NJ 0.375MG
(SUPPL-007) 07110 0.75MG
(NEW INDICATION --
IN COMBINATION WITH
ZIDOVUDINE TREATMENT OF HIV
INFECTION IN PATIENTS
WITH LIMITED PRIOR EXPOSURE
TO ZIDOVUDINE (<3 MONTHS))
20-469 VANCENASE AQ SCHERING BECLOMETHASONE DIPROPIONATE
26-JUN-96 (SPRAY, METERED) KENILWORTH, NJ MONOHYDRATE
(3 S) 07033 EQ 0.084MG DIPROP/INH
(CORTICOSTEROID)
[RELIEF OF SYMPTOMS OF
ALLERGIC AND NONALLERGIC
RHINITIS AND PREVENTION OF
RECURRENCE OF NASAL POLYPS
FOLLOWING SURGICAL REMOVAL]
20-638 VISTIDE GILEAD CIDOFOVIR
26-JUN-96 (INJECTABLE) FOSTER CITY, CA EQ 75MG BASE/ML
(1 S) 94404 (ANTIVIRAL)
[TREATMENT OF
CYTOMEGALOVIRUS RETINITIS
IN PATIENTS WITH AIDS)
20-589 CHILDREN'S ADVIL WHITEHALL ROBINS IBUPROFEN
27-JUN-96 (SUSPENSION) MADISON, NJ 100MG/5ML
(6 S) 07940 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[TEMPORARY RELIEF OF
MINOR ACHES AND PAINS
AND THE REDUCTION OF IN
FEVER IN CHILDREN
2 YEARS OF AGE AND OLDER]
(OTC)
18-922 LODINE WYETH AYERST ETODOLAC
28-JUN-96 (CAPSULE) PHILADELPHIA, PA 200MG
(SUPPL-013) 19101 300MG
(NEW INDICATION --
RHEUMATOID ARTHRITIS)
18-922 LODINE WYETH AYERST ETODOLAC
28-JUN-96 (TABLET) PHILADELPHIA, PA 400MG
(SUPPL-013) 19101 500MG
(NEW INDICATION --
RHEUMATOID ARTHRITIS)
18-922 LODINE WYETH AYERST ETODOLAC
28-JUN-96 (TABLET) PHILADELPHIA, PA 400MG
(SUPPL-014) 19101 500MG
(NEW DOSAGE REGIMEN --
NEW 500MG DOSAGE STRENGTH)
50-673 CECLOR CD LILLY CEFACLOR
28-JUN-96 (TABLET, INDIANAPOLIS, IN EQ 375MG BASE
(3 S) EXTENDED RELEASE) 46285 EQ 500MG BASE
(ANTIBIOTIC, CEPHEM)
An approvable letter indicates that FDA is prepared to approve the application
upon the satisfaction of conditions specified in the approvable letter.
Drug products which are the subject of approvable letters may not be legally
marketed until the firm has satisfied the identified deficiencies, as well as
any other requirements that may be imposed by FDA, and has been notified in
writing that the application has been approved. Further information on
approvable NDAs is not subject to Freedom of Information (FOI) release until
applications are approved.
50-719 HELIDAC KIT PROCTOR GAMBLE PHARM BISMUTH SUBSALICYLATE
05-JUN-96 (TABLET, CHEWABLE; CINCINNATI, OH 262.4MG/TABLET CHEWABLE
TABLET; 45241 METRONIDAZOLE
CAPSULE) 250MG/TABLET
TETRACYCLINE
500MG/CAPSULE
(ANTIULCER)
20-593 DEPACON ABBOTT VALPROATE SODIUM
06-JUN-96 (INJECTABLE) ABBOTT PARK, IL EQ 100MG ACID/ML
60064 (ANTICONVULSANT)
20-441 PULMICORT-200 ASTRA BUDESONIDE
14-JUN-96 (AEROSOL, METERED) WESTBOROUGH, MA 0.2MG/INH
01581 (CORTICOSTEROID)
20-441 PULMICORT-400 ASTRA BUDESONIDE
14-JUN-96 (AEROSOL, METERED) WESTBOROUGH, MA 0.4MG/INH
01581 (CORTICOSTEROID)
20-448 IMODIUM A-D MCNEIL CONS PRODS LOPERAMIDE HYDROCHLORIDE
14-JUN-96 (TABLET, CHEWABLE) FORT WASHINGTON, PA 2MG
19034 (ANTIDIARRHEAL)
20-533 NAROPIN ASTRA ROPIVACAINE HYDROCHLORIDE
28-JUN-96 (INJECTABLE) WESTBOROUGH, MA 2MG/ML
01581 5MG/ML
7.5MG/ML
10MG/ML
(ANESTHETIC, LOCAL)
64-084 BLEOMYCIN SULFATE PHARMACIA BLEOMYCIN SULFATE
01-JUN-96 (INJECTABLE) COLUMBUS, OH EQ 15 UNITS BASE/VIAL*
43216 EQ 30 UNITS BASE/VIAL
(ANTINEOPLASTIC)
74-137* BUPRENORPHINE HCL SANOFI WINTHROP BUPRENORPHINE HYDROCHLORIDE
03-JUN-96 (INJECTABLE) NEW YORK, NY EQ 0.3MG BASE/ML
10016 (ANALGESIC)
74-148 PIROXICAM ZENITH GOLDLINE PIROXICAM
03-JUN-96 (CAPSULE) NORTHVALE, NJ 10MG
07647 20MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
40-007 HEPARIN SODIUM MARSAM HEPARIN SODIUM
07-JUN-96 (INJECTABLE) CHERRY HILL, NJ 1,000 UNITS/ML
08034 (ANTICOAGULANT)
74-286* DESOXIMETASONE TARO DESOXIMETASONE
07-JUN-96 (OINTMENT) BRAMALEA, ONTARIO 0.25%
CANADA (ANTI-INFLAMMATORY)
74-701* TRIAMTERENE AND MYLAN PHARMS HYDROCHLOROTHIAZIDE
07-JUN-96 HYDROCHLOROTHIAZIDE MORGANTOWN, WV 25MG
(CAPSULE) 26504 TRIAMTERENE
37.5MG
(DIURETIC)
74-604 DIFLUNISAL GENEVA PHARMS DIFLUNISAL
10-JUN-96 (TABLET) BROOMFIELD, CO 500MG
80038 (NONSTEROIDAL
ANTI-INFLAMMATORY)
* - First Time Product Available Generically
74-722 INDAPAMIDE PUREPAC PHARM INDAPAMIDE
17-JUN-96 (TABLET) ELIZABETH, NJ 1.25MG
07207 2.5MG
(ANTIHYPERTENSIVE/
DIURETIC)
74-242 NAPROXEN SODIUM SIDMAK LABS NJ NAPROXEN SODIUM
20-JUN-96 (TABLET) EAST HANOVER, NJ EQ 250MG BASE
07936 EQ 500MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
64-145 CEFACLOR NOVOPHARM CEFACLOR
24-JUN-96 (CAPSULE) SCARBOROUGH, ONTARIO EQ 250MG BASE
CANADA EQ 500MG BASE
(ANTIBIOTIC, CEPHEM)
74-182 NAPROXEN SIDMAK LABS NJ NAPROXEN
27-JUN-96 (TABLET) EAST HANOVER, NJ 250MG
07936 375MG
500MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-549 KETAMINE HCL SANOFI WINTHROP KETAMINE HYDROCHLORIDE
27-JUN-96 (INJECTABLE) NEW YORK, NY EQ 50MG BASE/ML
10016 EQ 100MG BASE/ML
(ANESTHETIC, GENERAL)
A tentative approval indicates that FDA has given an abbreviated new drug
application (ANDA) or 505(b)(2) application provisional approval under the
terms of the Drug Price Competition and Patent Term Restoration Act. Such
drug products that are the subjects of tentative approvals may not be legally
marketed until the market exclusivity and/or patent term of the listed
reference drug product has expired. Final approval is also contingent upon
conditions and information available to FDA remaining acceptable. When the
application receives final approval, the product may be legally marketed. The
effective approval date will be listed in this publication and in the
"Approved Drug Products with Therapeutic Equivalence Evaluations" list
published by FDA. Additional information on these applications will become
available to the public when the applications receive final approval.
74-515 TIMOLOL MALEATE AKRON TIMOLOL MALEATE
17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.25% BASE
62525 (BETA ADRENERGIC BLOCKER)
74-516 TIMOLOL MALEATE AKRON TIMOLOL MALEATE
17-JUN-96 (SOLUTION) DECATUR, IL EQ 0.5% BASE
62525 (BETA ADRENERGIC BLOCKER)
16-096 MINTEZOL MSD THIABENDAZOLE
03-JUN-96 (TABLET, CHEWABLE) WEST POINT, PA 500MG
19486 (LABELING REVISION --
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
16-097 MINTEZOL MSD THIABENDAZOLE
03-JUN-96 (SUSPENSION) WEST POINT, PA 500MG/5ML
19486 (LABELING REVISION --
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
19-616 PENETREX RHONE POULENC RORER ENOXACIN
03-JUN-96 (TABLET) COLLEGEVILLE, PA 200MG
19426 400MG
(LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS)
20-088 NORPLANT SYSTEM WYETH AYERST LEVONORGESTREL IMPLANT
03-JUN-96 (IMPLANT) PHILADELPHIA, PA 36MG/IMPLANT
19101 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
PATIENT PACKAGE INSERT)
18-342 WELLCOVORIN GLAXO WELLCOME LEUCOVORIN CALCIUM
06-JUN-96 (TABLET) RES TRIANGLE PK, NC EQ 5MG BASE
27709 EQ 25MG BASE
(LABELING REVISION --
WARNINGS)
20-219 LIVOSTIN CIBA VISION LEVOCABASTINE
10-JUN-96 (SUSPENSION, DROPS) DULUTH, GA HYDROCHLORIDE
30155 EQ 0.05% BASE
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-787 NORVASC PFIZER AMLODIPINE BESYLATE
14-JUN-96 (TABLET) GROTON, CT EQ 2.5MG BASE
06340 EQ 5MG BASE
EQ 10MG BASE
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS)
20-075 LIORESAL MEDTRONIC BACLOFEN
14-JUN-96 (INJECTABLE) MINNEAPOLIS, MN 0.5MG/ML
55432 2MG/ML
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-606 VANCOCIN HCL LILLY VANCOMYCIN HYDROCHLORIDE
14-JUN-96 (CAPSULE) INDIANAPOLIS, IN EQ 125MG BASE
46285 EQ 250MG BASE
(LABELING REVISION --
PRECAUTIONS)
19-887 NEBUPENT FUJISAWA PENTAMIDINE ISETHIONATE
19-JUN-96 (POWDER DEERFIELD, IL 300MG/VIAL
FOR RECONSTITUTION) 60015 (LABELING REVISION --
PRECAUTIONS)
18-723 DEPAKOTE ABBOTT DIVALPROEX SODIUM
20-JUN-96 (TABLET, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
DELAYED RELEASE) 60064 EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-680 DEPAKOTE ABBOTT DIVALPROEX SODIUM
20-JUN-96 (CAPSULE, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
DELAYED RELEASE 60064 (LABELING REVISION --
PELLETS) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-578 FORTAZ GLAXO WELLCOME CEFTAZIDIME
20-JUN-96 (INJECTABLE) RES TRIANGLE PK, NC 500MG/VIAL
27709 1GM/VIAL
2GM/VIAL
6GM/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
50-634 FORTAZ GLAXO WELLCOME CEFTAZIDIME SODIUM
20-JUN-96 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 20MG BASE/ML
(INJECTABLE) 27709 EQ 40MG BASE/ML
(LABELING REVISION --
ADVERSE REACTIONS)
50-646 CEPTAZ GLAXO WELLCOME CEFTAZIDIME
20-JUN-96 (INJECTABLE) RES TRIANGLE PK, NC [ARGININE FORMULATION]
27709 1GM/VIAL
2GM/VIAL
10GM/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
12-649 PERIACTIN MERCK CYPROHEPTADINE
21-JUN-96 (TABLET) WEST POINT, PA HYDROCHLORIDE
19486 4MG
(LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
13-220 PERIACTIN MERCK CYPROHEPTADINE
21-JUN-96 (SYRUP) WEST POINT, PA HYDROCHLORIDE
19486 2MG/5ML
(LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
17-603 NOVAFED MARION MERREL DOW PSEUDOEPHEDRINE
21-JUN-96 (CAPSULE, KANSAS CITY, MO HYDROCHLORIDE
EXTENDED RELEASE) 64134 120MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
18-554 EULEXIN SCHERING FLUTAMIDE
21-JUN-96 (CAPSULE) KENILWORTH, NJ 125MG
07033 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE)
19-050 SUFENTA JANSSEN SUFENTANIL CITRATE
21-JUN-96 (INJECTABLE) TITUSVILLE, NJ EQ 0.05MG BASE/ML
08560 (LABELING REVISION --
CONTRAINDICATIONS;
ADVERSE REACTIONS)
20-553 OXYCONTIN PURDUE OXYCODONE HYDROCHLORIDE
21-JUN-96 (TABLET, NORWALK, CT 10MG
EXTENDED RELEASE) 06850 20MG
40MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
17-854 REGLAN AH ROBINS METOCLOPRAMIDE
24-JUN-96 (TABLET) PHILADELPHIA, PA HYDROCHLORIDE
19101 EQ 5MG BASE
EQ 10MG BASE
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
17-862 REGLAN AH ROBINS METOCLOPRAMIDE
24-JUN-96 (INJECTABLE) PHILADELPHIA, PA HYDROCHLORIDE
19101 EQ 10MG BASE/2ML
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-821 REGLAN AH ROBINS METOCLOPRAMIDE
24-JUN-96 (SOLUTION) PHILADELPHIA, PA HYDROCHLORIDE
19101 EQ 5MG BASE/5ML
(PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
09-330 LANOXIN GLAXO WELLCOME DIGOXIN
25-JUN-96 (INJECTABLE) RES TRIANGLE PK, NC 0.25MG/ML
27709 (LABELING REVISION --
PRECAUTIONS;
OVERDOSAGE)
09-330 LANOXIN PEDIATRIC GLAXO WELLCOME DIGOXIN
25-JUN-96 (INJECTABLE) RES TRIANGLE PK, NC 0.1MG/ML
27709 (LABELING REVISION --
PRECAUTIONS;
OVERDOSAGE)
18-118 LANOXICAPS GLAXO WELLCOME DIGOXIN
25-JUN-96 (CAPSULE) RES TRIANGLE PK, NC 0.05MG
27709 0.1MG
0.2MG
(LABELING REVISION --
PRECAUTIONS;
OVERDOSAGE)
19-962 TOPROL-XL ASTRA METOPROLOL SUCCINATE
25-JUN-96 (TABLET, WESTBOROUGH, MA EQ 50MG TARTRATE
EXTENDED RELEASE) 01581 EQ 100MG TARTRATE
EQ 200MG TARTRATE
(LABELING REVISION --
OVERDOSAGE)
20-151 EFFEXOR WYETH AYERST VENLAFAXINE HYDROCHLORIDE
25-JUN-96 (TABLET) PHILADELPHIA, PA EQ 25MG BASE
19101 EQ 37.5MG BASE
EQ 50MG BASE
EQ 75MG BASE
EQ 100MG BASE
(LABELING REVISION --
ADVERSE REACTIONS;
OVERDOSAGE)
20-152 SERZONE BRISTOL MYERS SQUIBB NEFAZODONE HYDROCHLORIDE
25-JUN-96 (TABLET) WALLINGFORD, CT 100MG
06492 150MG
200MG
250MG
(LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
26-JUN-96 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
26-JUN-96 (POWDER WALLINGFORD, CT 100MG/PACKET
FOR RECONSTITUTION) 06492 167MG/PACKET
250 MG/PACKET
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
26-JUN-96 (POWDER WALLINGFORD, CT 10MG/ML
FOR RECONSTITUTION) 06492 (LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS)
20-164 LOVENOX RHONE POULENC RORER ENOXAPARIN SODIUM
26-JUN-96 (INJECTABLE) COLLEGEVILLE, PA 30MG/0.3ML
19426 (LABELING REVISION --
WARNINGS; DOSAGE AND
ADMINISTRATION)
20-199 HIVID ROCHE ZALCITABINE
26-JUN-96 (TABLET) NUTLEY, NJ 0.375MG
07110 0.75MG
(LABELING REVISION --
BOXED WARNINGS;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE
26-JUN-96 (CAPSULE) NUTLEY, NJ EQ 200MG BASE
07110 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
20-379 CAVERJECT UPJOHN ALPROSTADIL
27-JUN-96 (INJECTABLE) KALAMAZOO, MI 0.005MG/VIAL
49001 O.O1MG/VIAL
0.02MG/VIAL
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
17-447 NORPACE SEARLE DISOPYRAMIDE PHOSPHATE
28-JUN-96 (CAPSULE) SKOKIE, IL EQ 100MG BASE
60077 EQ 150MG BASE
(LABELING REVISION --
WARNINGS)
18-655 NORPACE CR SEARLE DISOPYRAMIDE PHOSPHATE
28-JUN-96 (CAPSULE, SKOKIE, IL EQ 100MG BASE
EXTENDED RELEASE) 60077 EQ 150MG BASE
(LABELING REVISION --
WARNINGS)
18-922 LODINE WYETH AYERST ETODOLAC
28-JUN-96 (CAPSULE) PHILADELPHIA, PA 200MG
19101 300MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
18-922 LODINE WYETH AYERST ETODOLAC
28-JUN-96 (TABLET) PHILADELPHIA, PA 400MG
19101 500MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-379 CAVERJECT UPJOHN ALPROSTADIL
28-JUN-96 (INJECTABLE) KALAMAZOO, MI 0.005MG/VIAL
49001 O.O1MG/VIAL
0.02MG/VIAL
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
0234 NONE CENTRAL BLOOD BANK CRYOPRECIPITATED AHF
26-JUN-96 (INJECTABLE) PITTSBURG, PA (B)
15219
0843 NONE CIVITAN REG BLOOD CTR CRYOPRECIPITATED AHF
26-JUN-96 (INJECTABLE) GAINESVILLE, FL (B)
32601
1205 CEA-SCAN IMMUNOMEDICS IMAGING AGENT
28-JUN-96 (NONE) MORRIS PLAINS, NJ (A,B)
07950
1206 NONE CHARLES RIVER DIV IMMU-4 BULK
28-JUN-96 (NONE) WILMINGTON PARTNERS (A,B)
WILMINGTON, MA
01887
***ERRATA***
1204 AVONEX BIOGEN INTERFERON BETA-1A*
27-MAY-96 (INJECTABLE) CAMBRIDGE, MA (A,B)
02142
* - A typographical error was made in May 1996 DDPA.
(A) Establishment License Issued
(B) Product License Issued
BP950004 ORASURE HIV-1 EPITOPE HIV SAMPLE COLLECTION KIT
03-JUN-96 WESTERN BLOT KIT BEAVERTON, OR (D)
97005
BP950005 ROCHE AMPLICOR ROCHE MOLECULAR SYS HIV MONITOR TEST
03-JUN-96 HIV-1 MONITOR SOMERVILLE, NJ (D)
TEST 08876
(D) Approved
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION
RESOURCES PRIOR TO PUBLICATION
P910074 CONTACLAIR EUREXPAN INDICATED FOR
06/20/96 MULTI-PURPOSE LABORATORIES CLEANING, RINSING,
SOLUTION CELLETTES, FR DISINFECTING AND
STORING DAILY AND
EXTENDED WEAR CLEAR
AND TINTED SOFT
CONTACT LENSES
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION
RESOURCES PRIOR TO PUBLICATION
P820018/S069 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER SYSTEMS NETWORK PROGRAMMER
MODEL 9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3
P830071/S006 ALCON WETTING, ALCON LABORATORIES, ALTERNATE FORMULATION
06/04/96 SOAKING, INC. DEVICE INDICATED FOR
CONDITIONING, AND FORT WORTH, TX THE DISINFECTION AND
DISINFECTING 76134-2099 CONDITIONING AFTER
SOLUTION ID 84392 CLEANING AND RINSING
OF CLEAR AND TINTED
DAILY AND EXTENDED
WEAR
P840024/S063 NUCLEUS 22 COCHLEAR REVISIONS TO THE
06/20/96 CHANNEL COCHLEAR CORPORATION WARNINGS SECTION IN
IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT
80112 AND PATIENT
IDENTIFICATION CARD
P840024/S064 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI
06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S
IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT(IC)
80112 (IC2401) THE NEW IC
IS DESIGNED TO
OPTIMIZE ELECTROSTATIC
DISCHARGE PROTECTION
OF THE MINI COCHLEAR
IMPLANT, MODEL C122M
P840039/S049 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34 D)
TO (-18.0 D) - (+45 D)
P840064/S017 VISCOAT ALCON LABORATORIES, 1) ALTERNATE
06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS;
SOLUTION FORT WORTH, TX USING 100% ETHYLENE
76134-2099 OXIDE 2) SHELF LIFE OF
24 MONTHS FOR VISCOAT
AND 36 MONTHS FOR
PROVISC; AND 3)
ALTERNATE PACKAGING
FOR PROVISC
P840068/S019 VISTA DDD MODEL CPI/GUIDANT TWO NEW MODELS OF
06/19/96 942, 944, AND CORPORATION VISTA DDD PULSE
SOFTWARE MODULE ST. PAUL, MN GENERATORS AND A
MODEL 2052 55112-5798 SOFTWARE MODULE
P860002/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34 D)
TO (-18.0 D) - (+45 D)
P860019/S108 SCIMED WAVE SCIMED LIFE SYSTEMS, INTENDED FOR THE
06/10/96 PERCUTANEOUS INC. BALLOON DILATATION
TRANSLUMINAL MAPLE GROVE, MN OF THE STENOTIC
CORONARY 55311-1566 PORTION OF A CORONARY
ANGIOPLASTY ARTERY OR BYPASS GRAFT
(PTCA) STENOSIS FOR THE
PERFUSION CATHETER PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P870018/S014 LITHOSTAR SIEMENS MEDICAL 1)MODIFICATIONS TO A
06/06/96 SHOCK WAVE SYSTEMS, INC. PROGRAMMABLE READ
SYSTEM C ISELIN, NJ ONLY MEMORY INTEGRATED
08830 CIRCUIT; AND 2)MINOR
LABELING CHANGES
P870018/S015 MOBILE SIEMENS MEDICAL APPROVAL FOR A MOBILE
06/05/96 LITHOSTAR SYSTEM, INC. VERSION OF THE
WITH SHOCK ISELIN, NJ LITHOSTAR SHOCK WAVE
WAVE SYSTEM C 08830 SYSTEM C
(SWSC)
P870018/S016 LITHOSTAR SIEMENS MEDICAL MODIFICATION OF
06/21/96 LITHOTRIPTER SYSTEMS, INC. USER'S MANUAL
ISELIN, NJ
08830
P870076/S004 FALOPE-RING CIRCON-CABOT MEDICAL ALTERNATE
06/14/96 BAND CORPORATION MANUFACTURING SITE
CONTRACEPTIVE LANGHORNE, PA
TUBAL OCCLUSION 19047
SYSTEM
P880003/S054 CORDIS PERCUTANEOUS CORDIS CORPORATION ALTERNATE
06/13/96 TRANSLUMINAL MIAMI, FL STERILIZATION SITE
CORONARY 33102-5700 (ISOMEDIX) IN
ANGIOPLASTY NORTHBOROUGH,
DILATATION CATHETERS MASSACHUSETTS
P880003/S059 CORDIS PERCUTANEOUS CORDIS CORPORATION MODIFIED BALLOON
06/05/96 TRANSLUMINAL MIAMI LAKES, FL FOLDING MACHINE
CORONARY 33014-5700
ANGIOPLASTY
(PTCA) DILATATION
CATHETERS
P880027/S038 ASUKA AND ASUKA SCHNEIDER (USA), INC. INDICATED FOR BALLOON
06/12/96 LONGY OVER-THE- PLYMOUTH, MN DILATATION OF THE
WIRE PERCUTANEOUS 55442 STENOTIC PORTION OF
TRANSLUMINAL CORONARY A CORONARY ARTERY OR
ANGIOPLASTY (PTCA) BYPASS GRAFT STENOSIS
CATHETERS FOR THE PURPOSE OF
IMPROVING MYOCARDIAL
PERFUSION
P880038/S031 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER SYSTEMS NETWORK PROGRAMMER
MODEL 9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3
P880090/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE
06/05/96 ANTERIOR CHAMBER INC. POWER RANGE FOR THE
INTRAOCULAR CLEARWATER, FL ONE-PIECE ANTERIOR
LENSES (IOLS) 34619 CHAMBER IOLS FROM
(+4.0 D) - (+34D) TO
(-4.5 D) - (+45D)
P890001/S011 LEOCOR PERCUTANEOUS LEOCOR, INC. CHANGE IN THE
06/13/96 ANGIOPLASTY HOUSTON, TX INSTRUCTIONS FOR USE,
CATHETER (PTCA), 77058-2536 ADDITION OF A PUMP
MODEL 5S, LEOCOR HEAD WITH LONGER
CORFLO MODEL 7.5PT TUBING, CHANGE IN THE
COATED PTCA, AND CLEANING PROCESS, AND
CORFLO ADDITION OF STOPCOCKS
HEMOPERFUSION PUMP ON THE PUMPS
P890001/S014 LEOCOR PERCUTANEOUS LEOCOR, INC. REVISED LABELING
06/13/96 TRANSLUMINAL HOUSTON, TX
ANGIOPLASTY 77058-2536
CATHETER AND LEOCOR
PTCA CATHETER MODEL
PICO-ST (COATED)
P890001/S015 LEOCOR PICO LEOCOR, INC. EXTENSION OF THE
06/07/96 RUNNER PTCA HOUSTON, TX LEOCOR PICO RUNNER
CATHETER 77058-2536 PTCA CATHETER LINE TO
INCLUDE A 4.0MM
BALLOON DIAMETER
P890027/S032 NUCLEUS 22 COCHLEAR REVISIONS TO THE
06/13/96 CHANNEL COCHLEAR CORPORATION WARNING SECTION IN
IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT
80112 AND PATIENT
IDENTIFICATION CARD
P890027/S033 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI
06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S
IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT
80112 (IC2401)
P890047/S010 PROVISC ALCON LABORATORIES, 1) ALTERNATE
06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS
MATERIAL FORT WORTH, TX USING 100% ETHYLENE
76134-2099 OXIDE 2) SHELF LIFE
OF 24 MONTHS FOR
VISCOAT AND 36 MONTHS
FOR PROVISC 3)
ALTERNATE PACKAGING
FOR PROVISC
P890055/S001 M3000 CONSTANT ARROW ADDITION OF THE
06/27/96 FLOW IMPLANTABLE INTERNATIONAL "MODEL 3000
PUMP WITH BOLUS WALPOLE, MA MEDICATION
SAFETY VALVE 02081 CALCULATOR" TO THE
LABELING
P900047/S005 CLARIS ALLERGAN OPTICAL 1) DUPLICATE WET-N-
06/20/96 REWETTING DROPS IRVINE, CA SOAK REWETTING DROPS
91713-9534 UNDER THE TRADE NAME
CLARIS REWETTING
DROPS 2) ADDITIONAL
STATEMENT TO THE
DIRECTIONS SECTION
P900070/S006 META DDDR TELECTRONICS PACING APPROVAL FOR THE
06/28/96 PACEMAKER PULSE SYSTEMS, INC. META DDDR PACEMAKER
GENERATORS MODELS ENGLEWOOD, CO PULSE GENERATORS
1256, 1256D, & 80112 MODELS 1256, 1256D,
1256B (FORMERLY AND 1256B (FORMERLY
1256R) 1256R)
P900070/S011 META DDDR PACING TELECTRONICS PACING MODIFICATION IN THE
06/21/96 SYSTEM SYSTEMS, INC. PULSE GENERATOR
ENGLEWOOD, CO DESIGN IN THE
80112 TELEMETRY COIL
CONNECTION
P900070/S012 NETWORK TELECTRONICS PACING APPROVAL FOR THE
06/25/96 PROGRAMMER MODEL SYSTEMS, INC. NETWORK PROGRAMMER
9602 ENGLEWOOD, CO MODEL 9602 WITH
80112 APPLICATION SOFTWARE
VERSION R5.3.
P910023/S014 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR THE
06/11/96 THERAPY SUNNYVALE, CA VENTRITEX EXTERNAL
DEFIBRILLATOR 94086-6527 STIMULATOR ADAPTER
SYSTEM (VESA) AND THE
VENTRITEX HIGH
VOLTAGE Y-ADAPTER
P910023/S018 CADET TIERED VENTRITEX, INC. APPROVAL FOR TWO
06/11/96 THERAPY SUNNYVALE, CA HEADER CONFIGURATIONS
DEFIBRILLATOR 94086-6527 (MODELS V-105/V115
SYSTEM AND MODELS
V-105B/V-115B, AS
PART OF THE CADET
TIERED THERAPY
DEFIBRILLATOR SYSTEM
P920051/S003 STORZ MODULITH KARL STORZ NEW MODEL
06/21/96 LITHOTRIPTER, LITHOTRIPSY-AMERICA THE DEVICE, AS
MODEL SLX KENNESAW, GA MODIFIED, WILL BE
30144 MARKETED UNDER THE
TRADE NAME THE STORZ
MODULITH LITHOTRIPTER
MODEL SLX
P930029/S005 ADDITION OF RF MEDTRONIC ADDITION OF THE RF
06/11/96 PERFORMR CARDIOPULMONARY DIV. PERFORMR SERIES OF
SAN JOSE, CA CARDIAC ABLATION
95134-1806 CATHETERS FOR THE
ATAKR RFCA SYSTEM
P940034/S002 GEN-PROBE GEN-PROBE INC. MODIFIED PACKAGE
06/05/96 AMPLIFIED SAN DIEGO, CA INSERT TO INCLUDE
MYCOBACTERIUM 92121-1589 MORE DETAILS ON
TUBERCULOSIS ADEQUATE VORTEXING
DIRECT (MTD) TEST
P950014/S001 PROSTATRON EDAP TECHNOMED APPROVAL TO SUPPLY
06/20/96 GROUP (USA), INC. THE PROSTATRON
CAMBRIDGE, MA TREATMENT CATHETER
02139 (I.E., THE
PROSTAPROBE) IN
STERILE FORM
***ORIGINAL VETERINARY NADAs***
140-890 EXCENEL SWINE UPJOHN CEFTIOFUR
26-APR-96 (LIQUID SUSPENSION) KALAMAZOO, MI HYDROCHLORIDE
49001 50MG/ML
141-058 AVIAX;BMD;3-NITRO BRIOLER PFIZER SEMDURAMICIN
11-JUN-96 (TYPE A MEDICATED CHICKENS NEW YORK, NY 22.7GM SEMDURA-MICIN
ARTICLES FOR THE 10017 ACTIVITY/LB
MANUFACTURE OF BACITRACIN METHYLENE
TYPE C MEDICATED DISALICYLATE
FEEDS) 30, 50 AND 60GM BMD
ACTIVITY/LB
ROXARSONE
45.4, 90 AND 227GM
ROXARSONE ACTIVITY/LB
141-054 IVOMEC SWINE MERCK IVERMECTIN
25-JUN-96 PREMIX FOR SWINE (WEANED, RAHWAY, NJ 0.6%
LINCOMIX GROWING 07065 LINCOMYCIN
PREMIX AND 20GM/LB
(TYPE B OR C FINISHING 50GM/LB
MEDICATED FEEDS PIGS)
MADE FROM THE
COMBINATION OF
TYPE A MEDICATED
ARTICLES)
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-028 EVICT, LASSIE, DOGS LAMBERT KAY DIV PYRANTEL PAMOATE
28-MAR-96 VET'S OWN CARTER WALLACE 2.27MG/ML
(SUSPENSION) CRANBURY, NJ
08512
200-162 TRIPELENNAMINE CATTLES, PHOENIX SCI TRIPELENNAMINE
28-MAR-96 HYDROCHLORIDE HORSES ST JOSEPH, MO HYDROCHLORIDE
(INJECTABLE) 64506 20MG/ML
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-130 NEO-SOL 50 CATTLES WADE JONES NEOMYCIN SULFATE
08-MAY-96 (POWDER) (EXCLUDING LOWELL, AR 71.5GM/100GM
VEAL 72745
CALVES)
SWINE,
SHEEP,
GOATS
200-153 NEO 200 CATTLES RHONE MERIEUX NEOMYCIN SULFATE
08-MAY-96 (SUSPENSION) (EXCLUDING FORT DODGE, IA 200MG/ML
VEAL 50501
CALVES),
SWINE,
SHEEP,
GOATS)
200-154 OXYTETRACYCLINE 200 CATTLES, PENNFIELD OIL OXYTETRACYCLINE
08-MAY-96 (SOLUTION) SWINE OMAHA, NE 200MG/ML
68137
200-127 UNDETERMINED 1 TO 3-DAY UPJOHN SPECTINOMYCIN
09-MAY-96 (INJECTABLE) OLD TURKEY KALAMAZOO, MI HYDROCHLORIDE
POULTS AND 49001 100MG SPECTINOMYCIN
1 TO 3-DAY ACTIVITY/ML
OLD CHICKS
***SUPPLEMENTAL VETERINARY NADAs***
140-897 REVALOR-G CATTLE HOECHST ROUSSEL TRENBOLONE ACETATE
27-MAR-96 (IMPLANT) AGRA VET 2 PELLETS WITH
SOMERVILLE, NJ 20MG/PELLET
08876 ESTRADIOL
2 PELLETS WITH
4 MG/PELLET
128-620 SAGE-GUARD 10% CATTLE HOECHST ROUSSEL FENBENDAZOLE
28-MAR-96 (SUSPENSION) (INCLUDING AGRA VET 100MG/ML
DAIRY SOMERVILLE, NJ
CATTLE OF 08876
BREEDING
AGE)
***SUPPLEMENTAL VETERINARY NADAs***
132-872 SAGE-GUARD PASTE 10% CATTLE HOECHST ROUSSEL FENBENDAZOLE
28-MAR-96 (PASTE) (INCLUDING AGR VET 10%
DAIRY SOMERVILLE, NJ
CATTLE OF 08876
BREEDING
AGE)
137-600 SAGE-GUARD 20% CATTLE HOECHST ROUSSEL FENBENDAZOLE
28-MAR-96 TYPE A MEDICATED (INCLUDING AGR VET 20% TYPE A MEDICATED
ARTICLE DAIRY SOMERVILLE, NJ ARTICLE IN 25 LB BAG
0.5% CATTLE TOP CATTLE OF 08876 0.5% CATTLE TOP
DRESS BREEDING DRESSING IN 10 LB BAG
35% FREE-CHOICE AGE) 35% FREE-CHOICE
MINERAL MINERAL IN 24 AND
(TYPE A PREMIX) 40 LB BAGS
141-007 DRONTAL PLUS DOGS BAYER AGR DIV PRAZIQUANTEL
28-MAR-96 BROAD SPECTRUM AN HLTH PRDTS 22.7MG
ANTHELMINTIC SHAWNEE MISSION, KS 68MG
(TABLET) 66201 PYRANTEL PAMOATE
22.7MG
68MG
FEBANTEL
113.4MG
340MG
011-315 NEOMYCIN 325/ CATTLE, UPJOHN NEOMYCIN SULFATE
03-APR-96 NEOMIX AG 325 SHEEP, KALAMAZOO, MI 50GM/100GM PACKAGE
SOLUBLE POWDER SWINE, 49001 227.5GM/22.6KG
(POWDER) GOATS PACKAGE
200-046 NEOMYCIN SULFATE CATTLE, PFIZER NEOMYCIN SULFATE
03-APR-96 SOLUBLE POWDER SHEEP, NEW YORK, NY 227.5GM/LB
325 G/LB SWINE, 10017
(POWDER) GOATS
200-050 NEOMYCIN 325 CATTLE, RHONE MERIEUX NEOMYCIN SULFATE
03-APR-96 SOLUBLE POWDER SHEEP, FORT DODGE, IA 50GM/3.5OZ
(POWDER) SWINE, 50501
GOATS
140-998 V-MAX M CATTLE PFIZER VIRGINIAMYCIN
03-MAY-96 (TYPE A MEDICATED NEW YORK, NY 136.2GM/LB
ARTICLE USED IN 10017
THE MANUFACTURE OF
TYPE C MEDICATED
FEEDS)
Date created: August 19, 1996; last updated: June 20, 2005 |
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