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Drug Approvals for September 1997
Definitions and Notes
September 1997
Original New Drug Applications
Original Application #: 020758
Approval Date: 30-SEP-97
Trade Name: IRBESARTAN - HYDROCHLOROTHIAZIDE
Chemical Type: 1,4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; IRBESARTAN
OTC/RX Status: RX
Indication(s): Treatment of hypertension
Original Application #: 020757
Approval Date: 30-SEP-97
Trade Name: AVAPRO
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX
Indication(s): Treatment of hypertension
Original Application #: 020712
Approval Date: 30-SEP-97
Trade Name: CARBATROL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SHIRE LABORATORIES INC
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX
Indication(s): Use as an anticonvulsant drug and in the treatment of pain associated with true trigeminal neuralgia
Original Application #: 020646
Approval Date: 30-SEP-97
Trade Name: GABITRIL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): TIAGABINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): As adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures
Original Application #: 020405
Approval Date: 30-SEP-97
Trade Name: LANOXIN
Chemical Type: 7
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): DIGOXIN
OTC/RX Status: RX
Indication(s): Treament of heart failure in patients receiving angiotensin-converting enzyme inhibitors and diuretics or diuretics alone and for the control of ventricular response rate in patients with chronic atrial fibrillation
Original Application #: 020734
Approval Date: 29-SEP-97
Trade Name: CLINIMIX
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS; DEXTROSE
OTC/RX Status: RX
Indication(s): A source of calories and protein in patients where: (1) the alimentary tract cannot be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased
Original Application #: 020582
Approval Date: 29-SEP-97
Trade Name: FOLLISTIM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): FOLLITROPIN BETA
OTC/RX Status: RX
Indication(s): 1. The development of multiple follicles in ovulatory patients participating in Assisted Reproductive Technologies; and 2. The induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure
Original Application #: 020378
Approval Date: 29-SEP-97
Trade Name: GONAL-F
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): FOLLITROPIN ALFA
OTC/RX Status: RX
Indication(s): 1. The induction of ovulation and pregnancy in the anovulatory infertile patient in whom he cause of infertility is functional and not due to primary ovarian failure; and 2. The development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program
Original Application #: 020857
Approval Date: 26-SEP-97
Trade Name: COMBIVIR
Chemical Type: 4
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX
Indication(s): Treatment of HIV infection
Original Application #: 020780
Approval Date: 26-SEP-97
Trade Name: CIPRO
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Indication(s): Provides for a new formulation of Cipro and indications of acute sinusitis, lower respiratory tract infections, urinary tract infections, acute uncomplicated cystitis in females, chronic bacterial prostatitis, complicated intra-abdomial infections, skin and skin structure infections, bone and joint infections, infectious diarrhea, typhoid fever (enteric fever), and uncomplicated cervial and urethral gonorrhea
Original Application #: 020743
Approval Date: 26-SEP-97
Trade Name: NORITATE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: DERMIK LABORATORIES INC SUB RORER
Active Ingredient(s): METRONIDAZOLE
OTC/RX Status: RX
Indication(s): Topical treatment of inflammatory lesions and erythema of rosacea
Original Application #: 020639
Approval Date: 26-SEP-97
Trade Name: SEROQUEL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): QUETIAPINE FUMARATE
OTC/RX Status: RX
Indication(s): Treatment of the manifestations of psychotic disorders
Original Application #: 020443
Approval Date: 26-SEP-97
Trade Name: GEREF
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SERMORELIN ACETATE
OTC/RX Status: RX
Indication(s): Treatment of idiopathic growth hormone deficiency in children with growth failure
Original Application #: 020716
Approval Date: 23-SEP-97
Trade Name: VICOPROFEN
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): HYDROCODONE BITARTRATE; IBUPROFEN
OTC/RX Status: RX
Indication(s): Treatment of short-term (generally less than 10 days) management of acute pain
Original Application #: 019922
Approval Date: 23-SEP-97
Trade Name: CORLOPAM
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: NEUREX CORP
Active Ingredient(s): FENOLDOPAM MESYLATE
OTC/RX Status: RX
Indication(s): In-hospital, short-term (up to 48 hours) use in the management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function
Original Application #: 020692
Approval Date: 19-SEP-97
Trade Name: SEREVENT
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX
Indication(s): Maintenance treatment of asthma and in the prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma, who require regular treatment with inhaled, short-acting beta2-agonists
Original Application #: 020658
Approval Date: 19-SEP-97
Trade Name: REQUIP
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): ROPINIROLE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of the signs and symptoms of idiopathic Parkinson's disease
Original Application #: 020420
Approval Date: 12-SEP-97
Trade Name: GENESA
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: GENSIA INC
Active Ingredient(s): ARBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Aid in diagnosing the presence or absence of coronary artery disease in patients who cannot exercise adequately when used in conjunction with radionuclide myocardial perfusion imaging or echocardiography
Original Application #: 020624
Approval Date: 11-SEP-97
Trade Name: ANZEMET
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE
OTC/RX Status: RX
Indication(s): For the prevention of chemotherapy-induced emesis, prevention of postoperative nausea and vomiting, and treatment of postoperative nausea and vomiting
Original Application #: 020623
Approval Date: 11-SEP-97
Trade Name: ANZEMET
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE
OTC/RX Status: RX
Indication(s): For the prevention of chemotherapy-induced nausea and vomiting, and prevention of postoperative nausea and vomiting
Original Application #: 020111
Approval Date: 11-SEP-97
Trade Name: DYNA-HEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: XTTRIUM LABORATORIES INC
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX
Indication(s): Health-care personnel handwash
Original Application #: 020769
Approval Date: 08-SEP-97
Trade Name: LOCOID
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: INVERESK RESEARCH
Active Ingredient(s): HYDROCORTISONE BUTYRATE
OTC/RX Status: RX
Indication(s): Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
Original Application #: 020792
Approval Date: 05-SEP-97
Trade Name: CARDIZEM
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Continuous intravenous infusion for temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter
Efficacy Supplemental New Drug Applications
Application #: 020550 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the suppression of recurrent episodes of genital herpes in immunocompetent adults
Application #: 020468 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: NASACORT AQ
Dosage Form: SPRAY
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Efficacy Claim: Use in pediatric patients between the ages of 6 and 11 years for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis
Application #: 019383 Efficacy Supplement#: 011
Type: SE1 to Original New Drug Application
Approval Date: 18-SEP-97
Trade Name: PROVENTIL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Efficacy Claim: Provides pediatric labeling for children 6 to 12 years of age
Application #: 050605 Efficacy Supplement#: 025
Type: SE2 to Original New Drug Application
Approval Date: 17-SEP-97
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX
Efficacy Claim: Treatment of Secondary Bacterial Infections of Acute Bronchitis (SBIAB) with 5-day therapy
Application #: 020363 Efficacy Supplement#: 012
Type: SE1 to Original New Drug Application
Approval Date: 17-SEP-97
Trade Name: FAMVIR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): FAMCICLOVIR
OTC/RX Status: RX
Efficacy Claim: For the suppression of recurrent episodes of genital herpes in immunocompetent adults
Application #: 050662 Efficacy Supplement#: 019
Type: SE1 to Original New Drug Application
Approval Date: 16-SEP-97
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: Addition of a new therapy regimen to an existing indication; for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate Helicobacter pylori infection in combination with lansoprazole and amoxicillin
Application #: 020137 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 09-SEP-97
Trade Name: DEMADEX
Dosage Form: INJECTABLE
Applicant: BOEHRINGER MANNHEIM CORP THERAPEUTICS DIV
Active Ingredient(s): TORSEMIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of edema associated with chronic renal failure
Application #: 020136 Efficacy Supplement#: 009
Type: SE1 to Original New Drug Application
Approval Date: 09-SEP-97
Trade Name: DEMADEX
Dosage Form: TABLET
Applicant: BOEHRINGER MANNHEIM CORP THERAPEUTICS DIV
Active Ingredient(s): TORSEMIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of edema associated with chronic renal failure
Application #: 018140 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 05-SEP-97
Trade Name: ATIVAN
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LORAZEPAM
OTC/RX Status: RX
Efficacy Claim: Initial anticonvulsant treatment of status epilepticus
Approvable Original New Drug Applications
Original Application #: 020758
Approvable Date: 26-SEP-97
Trade Name: IRBESARTAN - HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; IRBESARTAN
OTC/RX Status: RX
Original Application #: 020757
Approvable Date: 26-SEP-97
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX
Original Application #: 020770
Approvable Date: 26-SEP-97
Trade Name: FLOVENT
Dosage Form: POWDER
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Original Application #: 020785
Approvable Date: 19-SEP-97
Trade Name: SYNOVIR
Dosage Form: CAPSULE
Applicant: CELGENE CORP
Active Ingredient(s): THALIDOMIDE
OTC/RX Status: RX
Original Application #: 020811
Approvable Date: 18-SEP-97
Trade Name: ACULAR
Dosage Form: SOLUTION/DROPS
Applicant: SYNTEX LABORATORIES INC SUB SYNTEX CORP
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Original Application #: 020607
Approvable Date: 17-SEP-97
Trade Name: ARTHROTEC
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): DICLOFENAC SODIUM; MISOPROSTOL
OTC/RX Status: RX
Original Application #: 020807
Approvable Date: 08-SEP-97
Trade Name: REFLUDAN
Dosage Form: INJECTABLE
Applicant: BEHRINGWERKE AG
Active Ingredient(s): LEPIRUDIN
OTC/RX Status: RX
Original Application #: 020767
Approvable Date: 05-SEP-97
Trade Name: PROPULSID QUICKSOLV
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): CISAPRIDE MONOHYDRATE
OTC/RX Status: RX
Original Application #: 020583
Approvable Date: 03-SEP-97
Trade Name: LOTEMAX
Dosage Form: SUSPENSION/DROPS
Applicant: PHARMOS CORP
Active Ingredient(s): LOTEPREDNOL ETABONATE
OTC/RX Status: RX
Original Abbreviated New Drug Applications
Original Abbreviated Application # 074942
Approval Date: 30-SEP-97
Trade Name: ETODOLAC
Dosage Form: CAPSULE
Applicant: INVAMED INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 074925
Approval Date: 30-SEP-97
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 074825
Approval Date: 30-SEP-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Application # 074824
Approval Date: 30-SEP-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064187
Approval Date: 30-SEP-97
Trade Name: ERYTHROMYCIN
Dosage Form: SOLUTION
Applicant: ALTANA INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064184
Approval Date: 30-SEP-97
Trade Name: ERYTHROMYCIN
Dosage Form: GEL
Applicant: ALTANA INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX
Original Abbreviated Application # 040196
Approval Date: 30-SEP-97
Trade Name: WARFARIN SODIUM
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): WARFARIN SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 040236
Approval Date: 25-SEP-97
Trade Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: HALSEY DRUG CO INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX
Original Abbreviated Application # 074955
Approval Date: 19-SEP-97
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Original Abbreviated Application # 074880
Approval Date: 17-SEP-97
Trade Name: ALBUTEROL SULFATE
Dosage Form: SOLUTION
Applicant: NEPHRON CORP
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 074680
Approval Date: 12-SEP-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074550
Approval Date: 11-SEP-97
Trade Name: GLIPIZIDE
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX
Original Abbreviated Application # 040218
Approval Date: 11-SEP-97
Trade Name: AMITRIPTYLINE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074857
Approval Date: 09-SEP-97
Trade Name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TRIAMTERENE
OTC/RX Status: RX
Original Abbreviated Application # 040245
Approval Date: 08-SEP-97
Trade Name: CARISOPRODOL
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): CARISOPRODOL
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval
Original Abbreviated Application #: 074858
Tentative Approval Date: 30-SEP-97
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Original Abbreviated Application #: 074752
Tentative Approval Date: 15-SEP-97
Trade Name: DILTIAZEM HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ANDRX CORP
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 074937
Tentative Approval Date: 05-SEP-97
Trade Name: IBUPROFEN
Dosage Form: SUSPENSION
Applicant: L PERRIGO CO
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC
Labeling Supplements to Original New Drug Applications
Application #: 020779 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 30-SEP-97
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020778 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 30-SEP-97
Trade Name: VIRACEPT
Dosage Form: POWDER FOR RECONSTITUTION
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020304 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 30-SEP-97
Trade Name: TRASYLOL
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): APROTININ
OTC/RX Status: RX
Application #: 020114 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 29-SEP-97
Trade Name: ASTELIN
Dosage Form: SPRAY
Applicant: WALLACE LABORATORIES DIV CARTER WALLACE INC
Active Ingredient(s): AZELASTINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020685 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Application #: 020685 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Application #: 020685 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Application #: 019858 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Application #: 019857 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Application #: 019847 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Application #: 019537 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 26-SEP-97
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020541 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 19-SEP-97
Trade Name: ARIMIDEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ANASTROZOLE
OTC/RX Status: RX
Application #: 019758 Labeling Supplement#: 035
To Original New Drug Application
Approval Date: 19-SEP-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX
Application #: 019297 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 19-SEP-97
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020509 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 18-SEP-97
Trade Name: GEMZAR
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): GEMCITABINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050662 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 16-SEP-97
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Application #: 017422 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 10-SEP-97
Trade Name: BICNU
Dosage Form: INJECTABLE
Applicant: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Active Ingredient(s): CARMUSTINE
OTC/RX Status: RX
Application #: 050456 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 09-SEP-97
Trade Name: STATROL
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OTC/RX Status: RX
Application #: 050344 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 09-SEP-97
Trade Name: STATROL
Dosage Form: OINTMENT
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OTC/RX Status: RX
Application #: 020708 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 04-SEP-97
Trade Name: LUPRON DEPOT-3
Dosage Form: INJECTABLE
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LEUPROLIDE ACETATE
OTC/RX Status: RX
Application #: 016979 Labeling Supplement#: 047
To Original New Drug Application
Approval Date: 04-SEP-97
Trade Name: MEGACE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX
Application #: 016885 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 04-SEP-97
Trade Name: LYSODREN
Dosage Form: TABLET
Applicant: BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO
Active Ingredient(s): MITOTANE
OTC/RX Status: RX
Application #: 020344 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 03-SEP-97
Trade Name: REDUX
Dosage Form: CAPSULE
Applicant: INTERNEURON PHARMACEUTICALS INC
Active Ingredient(s): DEXFENFLURAMINE HYDROCHLORIDE
OTC/RX Status: RX>
Application #:020027 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 02-SEP-97
Trade Name: CARDIZEM
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
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Date created: October 14, 1997; last updated; June 20, 2005 |
