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Drug Approvals for October 1996
Definitions and Notes
Original New Drug Applications
Original Application #: 019821
Approval Date: 28-OCT-96
Trade Name: SORIATANE
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: HOFFMAN-LAROCHE
Active Ingredient(s): ACITRETIN
OTC/RX Status: RX
Indication(s): Treatment of severe psoriasis
Original Application #: 020584
Approval Date: 25-OCT-96
Trade Name: LODINE XL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Indication(s): For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis
Original Application #: 020576
Approval Date: 25-OCT-96
Trade Name: CYSTADANE
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: POWDER
Applicant: ORPHAN MEDICAL INC
Active Ingredient(s): BETAINE, ANHYDROUS
OTC/RX Status: RX
Indication(s): For treatment of patients with homocystinuria
Original Application #: 020291
Approval Date: 24-OCT-96
Trade Name: COMBIVENT
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: AEROSOL, METERED
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
OTC/RX Status: RX
Indication(s): Use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator
Original Application #: 020591
Approval Date: 22-OCT-96
Trade Name: TARKA
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: KNOLL PHARMACEUTICAL CO SUB BASF CORP
Active Ingredient(s): TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of hypertension
Original Application #: 020524
Approval Date: 18-OCT-96
Trade Name: MENTAX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: PENEDERM INC
Active Ingredient(s): BUTENAFINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): TOPICAL APPLICATION IN THE TREATMENT OF INTERDIGITAL TINEA PEDIS
Original Application #: 020465
Approval Date: 17-OCT-96
Trade Name: AZULFIDINE EN-TABS
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: TABLET, DELAYED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX
Indication(s): Management of adults with active, classic and definitive rheumatoid arthritis who have had an insufficient therapeutic response to or are intolerant of an adequate trial of full doses of one or more non-steroidal anti- inflammatory drugs
Original Application #: 020641
Approval Date: 10-OCT-96
Trade Name: CLARITIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SYRUP
Applicant: SCHERING CORP
Active Ingredient(s): LORATADINE
OTC/RX Status: RX
Indication(s): Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for A e treatment of chronic idiopathic urticaria in patients six years of age or older
Original Application #: 020130
Approval Date: 09-OCT-96
Trade Name: ESTROSTEP
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
OTC/RX Status: RX
Indication(s): Prevention of pregnancy
Original Application #: 019764
Approval Date: 08-OCT-96
Trade Name: SAIZEN
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Indication(s): LONGTERM TREATMENT OF CHILDREN WITH GROWTH FAILURE DUE TO INADEQUATE SECRETION OF ENDOGENOUS GROWTH HORMONE
Original Application #: 020507
Approval Date: 04-OCT-96
Trade Name: TECZEM
Chemical Type: 2,4
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MERCK RESEARCH LABORATORIES DIV M>ICK AND CO
Active Ingredient(s): DILTIAZEM MALATE; ENALAPRIL MALEATE
OTC/RX Status: RX
Indication(s): TREATMENT OF HYPERTENSION
Original Application #: 020506
Approval Date: 04-OCT-96
Trade Name: TIAMATE
Chemical Type: 2
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO
Active Ingredient(s): DILTIAZEM MALATE
OTC/RX Status: RX
Indication(s): TREATMENT OF HYPERTENSION
Original Application #: 020358
Approval Date: 04-OCT-96
Trade Name: WELLBUTRIN SR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): TREATMENT OF DEPRESSION
Original Application #: 020615
Approval Date: 02-OCT-96
Trade Name: DURACLON
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): CLONIDINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): FOR THE CONTINUOUS EPIDURAL ADMINISTRATION AS ADJUNCTIVE THERAPY WITH INTRASPINAL OPIATES FOR THE TREATMENT OF SEVERE PAIN IN CANCER PATIENTS THAT IS NOT ADEQUATELY RELIEVED BY OPIOID ANALGESICS ALONE
Efficacy Supplemental New Drug Applications
Application #: 018298 Efficacy Supplement #: 024
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-96
Trade Name: TAVIST D
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
OTC/RX Status: OTC
Efficacy Claim: Relief of symptoms of common cold
Application #: 017661 Efficacy Supplement #: 048
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-96
Trade Name: TAVIST
Dosage Form: TABLET
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CLEMASTINE FUMARATE
OTC/RX Status: OTC
Efficacy Claim: Relief of symptoms of common cold
Application #: 018117 Efficacy Supplement #: 026
Type: SE2 to Original New Drug Application
Approval Date: 30-OCT-96
Trade Name: AZMACORT
Dosage Form: AEROSOL, METERED
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Efficacy Claim: Twice daily dosing and inclusion of patients who require a regular program of therapy for chronic asthma, whether or not they would need a systemic corticosteriod
Application #: 019839 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 25-OCT-96
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of obsessive compulsive disorder
Application #: 018874 Efficacy Supplement #: 007
Type: SE2 to Original New Drug Application
Approval Date: 22-OCT-96
Trade Name: CALCIJEX
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX
Efficacy Claim: Dose titration recommendations revision
Application #: 019858 Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 21-OCT-96
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Nosocomial Pneumonia - mild to moderate and severe caused by Haemophilus influenzae or Klebsiella pneumoniae
Application #: 019857 Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 21-OCT-96
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Nosocomial Pneumonia - mild to moderate and severe caused by Haemophilus influenzae or Klebsiella pneumoniae
Application #: 019847 Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 21-OCT-96
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Nosocomial Pneumonia - mild to moderate and severe caused by Haemophilus influenzae or Klebsiella pneumoniae
Application #: 050724 Efficacy Supplement #: 002
Type: SE1 to Original New Drug Application
Approval Date: 18-OCT-96
Trade Name: ABELCET
Dosage Form: INJECTABLE
Applicant: LIPOSOME CO INC
Active Ingredient(s): AMPHOTERICIN B LIPID COMPLEX
OTC/RX Status: RX
Efficacy Claim: Treatment of invasive fungal infections in patients who are efractory to or intolerant of conventional amphotericin B therapy
Application #: 019858 Efficacy Supplement #: 009
Type: SE1 to Original New Drug Application
Approval Date: 10-OCT-96
Trade Name: CIPRO IN SODIUM CHLORIDE 0.9%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Complicated intra-abdominal infections (used in combination with metronidazole) caused by mixed aerobic/anaerobic pathogens
Application #: 019857 Efficacy Supplement #: 011
Type: SE1 to Original New Drug Application
Approval Date: 10-OCT-96
Trade Name: CIPRO IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Complicated intra-abdominal infections (used in combination with metronidazole) caused by mixed aerobic/anaerobic pathogens
Application #: 019847 Efficacy Supplement #: 010
Type: SE1 to Original New Drug Application
Approval Date: 10-OCT-96
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX
Efficacy Claim: Complicated intra-abdominal infections (used in combination with metronidazole) caused by mixed aerobic/anaerobic pathogens
Application #: 019537 Efficacy Supplement #: 022
Type: SE1 to Original New Drug Application
Approval Date: 10-OCT-96
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Complicated intra-abdominal infections (used in combination with metronidazole) caused by mixed aerobic/anaerobic pathogens
Application #: 020013; Efficacy Supplement #: 007
Type: SE1 to Original New Drug Application
Approval Date: 09-OCT-96
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Preoperatively for the prevention of infection in transrectal prostate biopsy
Application #: 020550 Efficacy Supplement #: 001
Type: SE1 to Original New Drug Application
Approval Date: 04-OCT-96
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of initial episode genital herpes
Application #: 019910 ; Efficacy Supplement #: 018
Type: SE1 to Original New Drug Application
Approval Date: 04-OCT-96
Trade Name: RETROVIR
Dosage Form: SYRUP
Applicant: GLAXO-WELLCOME
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX
Efficacy Claim: Inclusion of new clinical trial data from ACTG 175
Application #: 019655 ; Efficacy Supplement #: 029
Type: SE1 to Original New Drug Application
Approval Date: 04-OCT-96
Trade Name: RETROVIR
Dosage Form: CAPSULE
Applicant: GLAXO-WELLCOME
Active Ingredient(s):ZIDOVUDINE
OTC/RX Status: RX
Efficacy Claim: Inclusion of new clinical trial data from ACTG 175
Approvable Original New Drug Applications
Original Application #: 020646
Approvable Date: 31-OCT-96
Trade Name: GABITRIL
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): TIAGABINE HYDROCHLORIDE
OTC/RX Status: RX
Original Application #: 020497
Approvable Date: 31-OCT-96
Trade Name: FARESTON
Dosage Form: TABLET
Applicant: ORION CORP
Active Ingredient(s): TOREMIFENE CITRATE
OTC/RX Status: RX
Original Application #: 050742
Approvable Date: 08-OCT-96
Trade Name: MECTIZAN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): IVERMECTIN
OTC/RX Status: RX
Original Application #: 020700
Approvable Date: 04-OCT-96
Trade Name: MUSE
Dosage Form: SUPPOSITORY
Applicant: VIVUS INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Original Application #: 020622
Approvable Date: 04-OCT-96
Trade Name: COPAXONE
Dosage Form: INJECTABLE
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): COPOLYMER 1
OTC/RX Status: RX
Original Application #: 020504
Approvable Date: 04-OCT-96
Trade Name: MICROZIDE
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Original Application #: 020644
Approvable Date: 02-OCT-96
Trade Name: SERLECT
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SERTINDOLE
OTC/RX Status: RX
Original Abbreviated New Drug Applications
Original Abbreviated Application # 074869
Approval Date: 31-OCT-96
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 074603
Approval Date: 31-OCT-96
Trade Name: GENERLAC
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): LACTULOSE
OTC/RX Status: RX
Original Abbreviated Application # 074498
Approval Date: 31-OCT-96
Trade Name: INDAPAMIDE
Dosage Form: TABLET
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): INDAPAMIDE
OTC/RX Status: RX
Original Abbreviated Application # 074780
Approval Date: 29-OCT-96
Trade Name: AKBETA
Dosage Form: SOLUTION
Applicant: AKORN INC
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074779
Approval Date: 29-OCT-96
Trade Name: AKBETA
Dosage Form: SOLUTION
Applicant: AKORN INC
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074851
Approval Date: 28-OCT-96
Trade Name: LEVOBUNOLOL HYDROCHLORIDE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074850
Approval Date: 28-OCT-96
Trade Name: LEVOBUNOLOL HYDROCHLORIDE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074670
Approval Date: 28-OCT-96
Trade Name: NICARDIPINE HYDROCHLORIDE
Dosage Form: CAPSULE
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074540
Approval Date: 28-OCT-96
Trade Name: NICARDIPINE HCL
Dosage Form: CAPSULE
Applicant: LEMMON CO SUB TAG PHARMACEUTICAL INC
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074474
Approval Date: 28-OCT-96
Trade Name: PINDOLOL
Dosage Form: TABLET
Applicant: MARTEC PHARMACEUTICALS INC
Active Ingredient(s): PINDOLOL
OTC/RX Status: RX
Original Abbreviated Application # 040185
Approval Date: 28-OCT-96
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 040153
Approval Date: 25-OCT-96
Trade Name: TRIFLUOPERAZINE HCL
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): TRIFLUOPERAZINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074523
Approval Date: 24-OCT-96
Trade Name: METRONIDAZOLE
Dosage Form: TABLET
Applicant: LABORATORIOS APLICACIONES FARMACEUTICAS SA DE CV
Active Ingredient(s): METRONIDAZOLE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application # 064101
Approval Date: 22-OCT-96
Trade Name: ERYTHRO-STATIN
Dosage Form: SOLUTION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX
Original Abbreviated Application # 074743
Approval Date: 18-OCT-96
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: SIGHT PHARMACEUTICALS INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC
Original Abbreviated Application # 074521
Approval Date: 18-OCT-96
Trade Name: DIPYRIDAMOLE
Dosage Form: INJECTABLE
Applicant: ELKINS SINN DIV AH ROBINS CO INC
Active Ingredient(s): DIPYRIDAMOLE
OTC/RX Status: RX
Original Abbreviated Application # 074228
Approval Date: 15-OCT-96
Trade Name: ETOPOSIDE
Dosage Form: INJECTABLE
Applicant: STERIS LABORATORIES INC
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX
Original Abbreviated Application # 074649
Approval Date: 03-OCT-96
Trade Name: CARBAMAZEPINE
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICAL INDUSTRIES LTD
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX
Original Abbreviated Application # 074554
Approval Date: 02-OCT-96
Trade Name: CHOLESTYRAMINE
Dosage Form: POWDER
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX
Original Abbreviated Application # 040161
Approval Date: 01-OCT-96
Trade Name: DICYCLOMINE HCL
Dosage Form: TABLET
Applicant: WEST WARD PHARMACEUTICAL CORP
Active Ingredient(s): DICYCLOMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval
Original Abbreviated Application #: 074732
Tentative Approval Date: 31-OCT-96
Trade Name: TAMOXIFEN CITRATE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS
Active Ingredient(s): TAMOXIFEN CITRATE
OTC/RX Status: RX
Original Abbreviated Application #: 074661
Tentative Approval Date: 03-OCT-96
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: L PERRIGO CO
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: OTC
Labeling Supplements to Original New Drug Applications
Application #: 018538 Labeling Supplement #: 021 To Original New Drug Application
Approval Date: 29-OCT-96
Trade Name: LOZOL
Dosage Form: TABLET
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): INDAPAMIDE
OTC/RX Status: RX
Application #: 019487 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 28-OCT-96
Trade Name: IMODIUM A-D
Dosage Form: SOLUTION
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: OTC
Application #: 018869 Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 24-OCT-96
Trade Name: NIMOTOP
Dosage Form: CAPSULE
Applicant: BAYER CORP
Active Ingredient(s): NIMODIPINE
OTC/RX Status: RX
Application #: 020356 Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 23-OCT-96
Trade Name: SULAR
Dosage Form: TABLET,EXTENDED RELEASE
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): NISOLDIPINE
OTC/RX Status: RX
Application #: 020313 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 22-OCT-96
Trade Name: MIACALCIN
Dosage Form: SPRAY, METERED
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CALCITONIN SALMON
OTC/RX Status: RX
Application #: 020264 Labeling Supplement #: 003 To Original New Drug Application
Approval Date: 22-OCT-96
Trade Name: MEGACE
Dosage Form: SUSPENSION
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): MEGESTROL ACETATE
OTC/RX Status: RX
Application #: 018044 Labeling Supplement #: 024 To Original New Drug Application
Approval Date: 22-OCT-96
Trade Name: ROCALTROL
Dosage Form: CAPSULE
Applicant: HOFFMANN LAROCHE INC
Active Ingredient(s): CALCITRIOL
OTC/RX Status: RX
Application #: 020379 Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 21-OCT-96
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Application #: 020550 Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 18-OCT-96
Trade Name: VALTREX
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): VALACYCLOVIR HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020541 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 18-OCT-96
Trade Name: ARIMIDEX
Dosage Form: TABLET
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): ANASTROZOLE
OTC/RX Status: RX
Application #: 019297 Labeling Supplement #: 012 To Original New Drug Application
Approval Date: 18-OCT-96
Trade Name: NOVANTRONE
Dosage Form: INJECTABLE
Applicant: IMMUNEX CORP
Active Ingredient(s): MITOXANTRONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020031 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 17-OCT-96
Trade Name: PAXIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 007073 Labeling Supplement #: 102 To Original New Drug Application
Approval Date: 17-OCT-96
Trade Name: AZULFIDINE
Dosage Form: TABLET, DELAYED RELEASE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX
Application #: 050662 Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: BIAXIN
Dosage Form: TABLET
Applicant: ABBOTT
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Application #: 050528 Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: DURICEF
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL
OTC/RX Status: RX
Application #: 050527 Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: DURICEF
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL
OTC/RX Status: RX
Application #: 050512 Labeling Supplement #: 043 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: DURICEF
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): CEFADROXIL
OTC/RX Status: RX
Application #: 011738 Labeling Supplement #: 011 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: NUMORPHAN
Dosage Form: SUPPOSITORY
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): OXYMORPHONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 011707 Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 15-OCT-96
Trade Name: NUMORPHAN
Dosage Form: INJECTABLE
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): OXYMORPHONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050581 Labeling Supplement #: 026 To Original New Drug Application
Approval Date: 11-OCT-96
Trade Name: MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX
Application #: 050517 Labeling Supplement #: 037 To Original New Drug Application
Approval Date: 11-OCT-96
Trade Name: MEFOXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): CEFOXITIN SODIUM
OTC/RX Status: RX
Application #: 050182 Labeling Supplement #: 027 To Original New Drug Application
Approval Date: 11-OCT-96
Trade Name: ERYTHROCIN LACTOBIONATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): ERYTHROMYCIN LACTOBIONATE
OTC/RX Status: RX
Application #: 020416 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 11-OCT-96
Trade Name: FERIDEX
Dosage Form: INJECTABLE
Applicant: ADVANCED MAGNETICS INC
Active Ingredient(s): FERUMOXIDES
OTC/RX Status: RX
Application #: 050632 Labeling Supplement #: 008 To Original New Drug Application
Approval Date: 10-OCT-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX
Application #: 050686 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 09-OCT-96
Trade Name: CEDAX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN DIHYDRATE
OTC/RX Status: RX
Application #: 050685 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 09-OCT-96
Trade Name: CEDAX
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): CEFTIBUTEN DIHYDRATE
OTC/RX Status: RX
Application #: 020199 Labeling Supplement #: 008 To Original New Drug Application
Approval Date: 04-OCT-96
Trade Name: HIVID
Dosage Form: TABLET
Applicant: HOFFMANN LAROCHE INC
Active Ingredient(s): ZALCITABINE
OTC/RX Status: RX
Application #: 017831; Labeling Supplement #: 049 To Original New Drug Application
Approval Date: 04-OCT-96
Trade Name: DIDRONEL
Dosage Form: TABLET
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): ETIDRONATE DISODIUM
OTC/RX Status: RX
Application #: 050095; Labeling Supplement #: 041 To Original New Drug Application
Approval Date: 03-OCT-96
Trade Name: CAPASTAT
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): CAPREOMYCIN SULFATE
OTC/RX Status: RX
Application #: 050630; Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 02-OCT-96
Trade Name: PRIMAXIN
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): IMIPENEM; CILASTATIN SODIUM
OTC/RX Status: RX
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Date created: November 18, 1996; last updated: June 20, 2005 |
