[Skip navigation]FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

Drug Approvals for July 1996

line

Definitions and Notes

Original New Drug Application


Original Application #: 020538
Approval Date: 31-JUL-96
Trade Name: ESTRADIOL
Chemical Type: Already marketed drug product but a new manufacturer
Therapeutic Potential: Standard review drug
Dosage Form: FILM, EXTENDED RELEASE
Applicant: MENOREST MANFACTURING INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Indication(s): TREATMENT OF ESTROGEN DEFICIENCY SYNDROME



Original Application #: 020526
Approval Date: 29-JUL-96
Trade Name: GYNE-LOTRIMIN 3 COMBINATION PACK
Chemical Type: Already marketed drug product, but a new use
Therapeutic Potential: Standard review drug
Dosage Form: SUPPOSITORY; CREAM
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC
Indication(s): TREATMENT OF RECURRENT VAGINAL YEAST INFECTIONS AND RELIEF OF ASSOCIATED EXTERNAL ITCHING AND IRRITATION OF THE VULVA



Original Application #: 020525
Approval Date: 29-JUL-96
Trade Name: GYNE-LOTRIMIN 3
Chemical Type: Already marketed drug product, but a new use
Therapeutic Potential: Standard review drug
Dosage Form: SUPPOSITORY
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: OTC
Indication(s): TREATMENT OF RECURRENT VAGINAL YEAST INFECTIONS



Original Application #: 020625
Approval Date: 25-JUL-96
Trade Name: ALLEGRA
Chemical Type: New molecular entity, or NME
Therapeutic Potential: Standard review drug
Dosage Form: CAPSULE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): FEXOFENADINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS



Original Application #: 020554
Approval Date: 22-JUL-96
Trade Name: DOVONEX
Chemical Type: New formulation
Therapeutic Potential: Standard review drug
Dosage Form: CREAM
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CALCIPOTRIENE
OTC/RX Status: RX
Indication(s): TREATMENT OF PLAQUE PSORIASIS



Original Application #: 050711
Approval Date: 18-JUL-96
Trade Name: ZITHROMAX
Chemical Type: New formulation
Therapeutic Potential: Standard review drug
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): AZITHROMYCIN DIHYDRATE
OTC/RX Status: RX
Indication(s): TREATMENT OF MILD TO MODERATE INFECTIONS CAUSED BY SUSCEPTIBLE STRAINS OF DESIGNATED MICROORGANISMS IN SPECIFIC CONDITIONS



Original Application #: 020630
Approval Date: 12-JUL-96
Trade Name: ULTIVA
Chemical Type: New molecular entity, or NME
Therapeutic Potential: Standard review drug
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): REMIFENTANIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): INDUCTION AND MAINTENANCE OF GENERAL ANESTHESIA, AND FOR CONTINUATION AS AN ANALGESIC INTO THE IMMEDIATE POSTOPERATIVE PERIOD; ALSO PROVIDES AN ANALGESIC COMPONENT OF MONITORED ANESTHESIA CARE



Original Application #: 020631
Approval Date: 03-JUL-96
Trade Name: MORPHINE SULFATE
Chemical Type: Already marketed drug product but a new manufacturer
Therapeutic Potential: Standard review drug
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT CHEMICAL INC
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Indication(s): RELIEF OF MODERATE TO SEVERE PAIN



Original Application #: 020616
Approval Date: 03-JUL-96
Trade Name: KADIAN
Chemical Type: New formulation
Therapeutic Potential: Standard review drug
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: FAULDING PHARMACEUTICAL CO SUB FH FAULDING AND CO LTD
Active Ingredient(s): MORPHINE SULFATE
OTC/RX Status: RX
Indication(s): MANAGEMENT OF MODERATE TO SEVERE PAIN WHERE TREATMENT WITH AN OPIOID ANALGESIC IS INDICATED FOR MORE THAN A FEW DAYS



Original Application #: 020536
Approval Date: 03-JUL-96
Trade Name: NICOTROL
Chemical Type: Already marketed drug product, but a new use
Therapeutic Potential: Standard review drug
Dosage Form: FILM, EXTENDED RELEASE
Applicant: MCNEIL CONSUMER PRODUCTS
Active Ingredient(s): NICOTINE
OTC/RX Status: OTC
Indication(s): AID TO SMOKING CESSATION


Efficacy Supplemental New Drug Applications


Application #: 050581; Efficacy Supplement #: 016
Type: SE1 to Original New Drug Application
Approval Date: 30-JUL-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
Efficacy Claim: ADDITION OF EIKENELLA CORRODENS TO THE PACKAGE INSERT



Application #: 050517; Efficacy Supplement #: 028
Type: SE1 to Original New Drug Application
Approval Date: 30-JUL-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
Efficacy Claim: ADDITION OF EIKENELLA CORRODENS TO THE PACKAGE INSERT



Application #: 020037; Efficacy Supplement #: 007
Type: SE1 to Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: VOLTAREN OPHTHALMIC
Dosage Form: SOLUTION/DROPS
Applicant: CIBA VISION OPHTHALMICS DIV CIBA VISION CORP
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX
Efficacy Claim: TREATMENT OF PHOTOPHOBIA



Application #: 050698; Efficacy Supplement #: 001
Type: SE1 to Original New Drug Application
Approval Date: 17-JUL-96
Trade Name: BIAXIN
Dosage Form: GRANULE, FOR RECONSTITUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): CLARITHROMYCIN
OTC/RX Status: RX
Efficacy Claim: TREATMENT OF COMMUNITY -ACQUIRED PNEUMONIA CAUSED BY MYCOPLASMA PNEUMONIAE, CHLAMYDIA PNEUMONIAE, AND STREPTOCOCCUS PNEUMONIAE IN CHILDREN



Application #: 020156; Efficacy Supplement #: 016
Type: SE1 to Original New Drug Application
Approval Date: 17-JUL-96
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: INCLUSION OF NEW CLINICAL TRIAL DATA



Application #: 020155; Efficacy Supplement #: 016
Type: SE1 to Original New Drug Application
Approval Date: 17-JUL-96
Trade Name: VIDEX
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: INCLUSION OF NEW CLINICAL TRIAL DATA



Application #: 020154; Efficacy Supplement #: 020
Type: SE1 to Original New Drug Application
Approval Date: 17-JUL-96
Trade Name: VIDEX
Dosage Form: TABLET, CHEWABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: INCLUSION OF NEW CLINICAL TRIAL DATA



Application #: 020036; Efficacy Supplement #: 011
Type: SE1 to Original New Drug Application
Approval Date: 16-JUL-96
Trade Name: AREDIA
Dosage Form: INJECTABLE
Applicant: CIBA GEIGY CORP PHARMACEUTICALS DIV
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Efficacy Claim: TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER



Application #: 019898; Efficacy Supplement #: 015
Type: SE1 to Original New Drug Application
Approval Date: 02-JUL-96
Trade Name: PRAVACHOL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): PRAVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE - REDUCE THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES


Approvable Original New Drug Applications


Original Application #: 020521
Approvable Date: 25-JUL-96
Trade Name: INFASURF
Dosage Form: SUSPENSION
Applicant: ONY INC
Active Ingredient(s): LUNG SURFACTANT EXTRACT, CALF
OTC/RX Status: RX



Original Application #: 020430
Approvable Date: 24-JUL-96
Trade Name: ORGARAN
Dosage Form: INJECTABLE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): DANAPAROID SODIUM
OTC/RX Status: RX



Original Application #: 020606
Approvable Date: 23-JUL-96
Trade Name: IMODIUM ADVANCED
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
OTC/RX Status: OTC



Original Application #: 020580
Approvable Date: 19-JUL-96
Trade Name: COTAZYM
Dosage Form: CAPSULE
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): PANCRELIPASE
OTC/RX Status: RX



Original Application #: 020601
Approvable Date: 11-JUL-96
Trade Name: CHILDREN'S MOTRIN
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC



Original Application #: 020601
Approvable Date: 11-JUL-96
Trade Name: JUNIOR STRENGTH MOTRIN
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC



Original Application #: 020453
Approvable Date: 11-JUL-96
Trade Name: PANDEL
Dosage Form: CREAM
Applicant: SAVAGE LABORATORIES INC DIV ALTANA INC
Active Ingredient(s): HYDROCORTISONE BUTEPRATE
OTC/RX Status: RX



Original Application #: 020584
Approvable Date: 03-JUL-96
Trade Name: LODINE XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: WYETH-AYERST
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX



Original Application #: 020519
Approvable Date: 02-JUL-96
Trade Name: LOPROX
Dosage Form: GEL
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): CICLOPIROX
OTC/RX Status: RX


Original Abbreviated New Drug Applications


Original Abbreviated Application # 074625
Approval Date : 31-JUL-96
Trade Name: OXYBUTYNIN CHLORIDE
Dosage Form: TABLET
Applicant: ROSEMONT PHARMACEUTICAL CORP
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX



Original Abbreviated Application # 040027
Approval Date : 31-JUL-96
Trade Name: PROMETHAZINE HCL AND DEXTROMETHORPHAN HYDROBROMIDE
Dosage Form: SYRUP
Applicant: HI TECHNOLOGY PHARMACAL CO INC
Active Ingredient(s): DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
OTC/RX Status: RX



Original Abbreviated Application # 074623
Approval Date : 30-JUL-96
Trade Name: LACTULOSE
Dosage Form: SOLUTION
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): LACTULOSE
OTC/RX Status: RX



Original Abbreviated Application # 074511
Approval Date : 30-JUL-96
Trade Name: SULSTER
Dosage Form: SOLUTION/DROPS
Applicant: AKORN INC
Active Ingredient(s): SULFACETAMIDE; PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX



Original Abbreviated Application # 040106
Approval Date : 30-JUL-96
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE
OTC/RX Status: RX



Original Abbreviated Application # 040105
Approval Date : 30-JUL-96
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE
OTC/RX Status: RX



Original Abbreviated Application # 074580
Approval Date : 29-JUL-96
Trade Name: CLOTRIMAZOLE
Dosage Form: SOLUTION
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): CLOTRIMAZOLE
OTC/RX Status: RX



Original Abbreviated Application # 040166
Approval Date : 26-JUL-96
Trade Name: ACETIC ACID
Dosage Form: SOLUTION/DROPS
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): ACETIC ACID, GLACIAL
OTC/RX Status: RX



Original Abbreviated Application # 040095
Approval Date : 26-JUL-96
Trade Name: HEPARIN SODIUM
Dosage Form: INJECTABLE
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): HEPARIN SODIUM
OTC/RX Status: RX



Original Abbreviated Application # 040069
Approval Date : 26-JUL-96
Trade Name: DEXAMETHASONE SODIUM PHOSPHATE
Dosage Form: SOLUTION/DROPS
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): DEXAMETHASONE SODIUM PHOSPHATE
OTC/RX Status: RX



Original Abbreviated Application # 074529
Approval Date : 24-JUL-96
Trade Name: ETOPOSIDE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): ETOPOSIDE
OTC/RX Status: RX



Original Abbreviated Application # 040101
Approval Date : 19-JUL-96
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX



Original Abbreviated Application # 074642
Approval Date : 18-JUL-96
Trade Name: NICARDIPINE HCL
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NICARDIPINE HYDROCHLORIDE
OTC/RX Status: RX



Original Abbreviated Antibiotic Application # 064030
Approval Date : 18-JUL-96
Trade Name: ERYTHROMYCIN
Dosage Form: OINTMENT
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX



Original Abbreviated Application # 040156
Approval Date : 15-JUL-96
Trade Name: HYDROXYZINE PAMOATE
Dosage Form: CAPSULE
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): HYDROXYZINE PAMOATE
OTC/RX Status: RX



Original Abbreviated Application # 074248
Approval Date : 12-JUL-96
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: OINTMENT
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX



Original Abbreviated Application # 040120
Approval Date : 11-JUL-96
Trade Name: PROCHLORPERAZINE MALEATE
Dosage Form: TABLET
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX



Original Abbreviated Application # 074249
Approval Date : 08-JUL-96
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: CREAM
Applicant: TARO PHARMACEUTICALS INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX



Original Abbreviated Antibiotic Application # 064128
Approval Date : 03-JUL-96
Trade Name: ERTHROMYCIN
Dosage Form: SWAB
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX



Original Abbreviated Antibiotic Application # 064126
Approval Date : 03-JUL-96
Trade Name: ERYTHROMYCIN
Dosage Form: SWAB
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): ERYTHROMYCIN
OTC/RX Status: RX


Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval


Original Abbreviated Application #: 074466
Tentative Approval Date: 30-JUL-96
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION/DROPS
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX



Original Abbreviated Application #: 074465
Tentative Approval Date: 30-JUL-96
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION/DROPS
Applicant: ADVANCED REMEDIES INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX



Original Abbreviated Application #: 074778
Tentative Approval Date: 26-JUL-96
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION/ DROPS
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX



Original Abbreviated Application #: 074776
Tentative Approval Date: 26-JUL-96
Trade Name: TIMOLOL MALEATE
Dosage Form: SOLUTION/ DROPS
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): TIMOLOL MALEATE
OTC/RX Status: RX


Labeling Supplements to Original New Drug Applications


Application #: 020596; Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX



Application #: 020564; Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX



Application #: 019309; Labeling Supplement #: 012 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: VASOTEC
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRILAT
OTC/RX Status: RX



Application #: 019221; Labeling Supplement #: 013 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: VASERETIC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE ; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX



Application #: 018998; Labeling Supplement #: 034 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: VASOTEC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX



Application #: 018709; Labeling Supplement #: 027 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: CAPOZIDE
Dosage Form: TABLET
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX



Application #: 018709; Labeling Supplement #: 026 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: CAPOZIDE
Dosage Form: TABLET
Applicant: ER SQUIBB AND SONS INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX



Application #: 018343; Labeling Supplement #: 068 To Original New Drug Application
Approval Date: 31-JUL-96
Trade Name: CAPOTEN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX



Application #: 050581; Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 30-JUL-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 #: 020226; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 30-JUL-96
Trade Name: NAPHCON-A
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
OTC/RX Status: OTC



Application #: 016211; Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 30-JUL-96
Trade Name: MIOCHOL
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: CIBA VISION OPHTHALMICS DIV CIBA VISION CORP
Active Ingredient(s): ACETYLCHOLINE CHLORIDE
OTC/RX Status: RX



Application #: 020363; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 29-JUL-96
Trade Name: FAMVIR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): FAMCICLOVIR
OTC/RX Status: RX



Application #: 020363; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 29-JUL-96
Trade Name: FAMVIR
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): FAMCICLOVIR
OTC/RX Status: RX



Application #: 020047; Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 29-JUL-96
Trade Name: DEXTROSE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DEXTROSE
OTC/RX Status: RX



Application #: 020047; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 29-JUL-96
Trade Name: DEXTROSE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DEXTROSE
OTC/RX Status: RX



Application #: 019937; Labeling Supplement #: 013 To Original New Drug Application
Approval Date: 29-JUL-96
Trade Name: ADENOCARD
Dosage Form: INJECTABLE
Applicant: MEDCO RESEARCH INC
Active Ingredient(s): ADENOSINE
OTC/RX Status: RX



Application #: 020071; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 26-JUL-96
Trade Name: DESOGEN
Dosage Form: TABLET
Applicant: ORGANON INC SUB AKZONA INC
Active Ingredient(s): DESOGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX



Application #: 020286; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 24-JUL-96
Trade Name: MONOPRIL-HCT
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX



Application #: 019915; Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 24-JUL-96
Trade Name: MONOPRIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): FOSINOPRIL SODIUM
OTC/RX Status: RX



Application #: 019826; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 24-JUL-96
Trade Name: THEOPHYLLINE IN DEXTROSE
Dosage Form: INJECTABLE
Applicant: MCGAW INC
Active Ingredient(s): THEOPHYLLINE
OTC/RX Status: RX



Application #: 020090; Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: DIFLUCAN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX



Application #: 020065; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: OPCON-A
Dosage Form: SOLUTION/DROPS
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
OTC/RX Status: OTC



Application #: 020065; Labeling Supplement #: 013 To Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: OPCON-A
Dosage Form: SOLUTION/DROPS
Applicant: BAUSCH AND LOMB INC
Active Ingredient(s): NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
OTC/RX Status: OTC



Application #: 019950; Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: DIFLUCAN
Dosage Form: INJECTABLE
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX



Application #: 019949; Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 23-JUL-96
Trade Name: DIFLUCAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX



Application #: 018981; Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 15-JUL-96
Trade Name: ENKAID
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): ENCAINIDE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 020489; Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 10-JUL-96
Trade Name: ANDRODERM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: THERATECH
Active Ingredients(s): TESTOSTERONE
OTC/RX Status: RX



Application #: 020387; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 18-JUL-96
Trade Name: HYZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX



Application #: 020386; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 18-JUL-96
Trade Name: COZAAR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): LOSARTAN POTASSIUM
OTC/RX Status: RX



Application #: 019717; Labeling Supplement #: 020 To Original New Drug Application
Approval Date: 10-JUL-96
Trade Name: HUMULIN 70/30
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN; INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC



Application #: 018781; Labeling Supplement #: 044 To Original New Drug Application
Approval Date: 10-JUL-96
Trade Name: HUMULIN N
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
OTC/RX Status: OTC



Application #: 018780; Labeling Supplement #: 051 To Original New Drug Application
Approval Date: 10-JUL-96
Trade Name: HUMULIN R
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): INSULIN BIOSYNTHETIC HUMAN
OTC/RX Status: OTC



Application #: 020236; Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 09-JUL-96
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX



Application #: 018533; Labeling Supplement #: 029 To Original New Drug Application
Approval Date: 08-JUL-96
Trade Name: NIZORAL
Dosage Form: TABLET
Applicant: JANSSEN PHARMACEUTICA INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX



Application #: 018013; Labeling Supplement #: 049 To Original New Drug Application
Permitted Date: 08-JUL-96
Trade Name: PAMELOR
Dosage Form: CAPSULE
Applicant: SANDOZ
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 018013; Labeling Supplement #: 046 To Original New Drug Application
Permitted Date: 08-JUL-96
Trade Name: PAMELOR
Dosage Form: CAPSULE
Applicant: SANDOZ
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 018012; Labeling Supplement #: 022 To Original New Drug Application
Permitted Date: 08-JUL-96
Trade Name: PAMELOR
Dosage Form: SOLUTION
Applicant: SANDOZ
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 018012; Labeling Supplement #: 021 To Original New Drug Application
Permitted Date: 08-JUL-96
Trade Name: PAMELOR
Dosage Form: SOLUTION
Applicant: SANDOZ
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 014685; Labeling Supplement #: 020 To Original New Drug Application
Approval Date: 08-JUL-96
Trade Name: AVENTYL HCL
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 014685; Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 08-JUL-96
Trade Name: AVENTYL HCL
Dosage Form: SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 014684; Labeling Supplement #: 035 To Original New Drug Application
Approval Date: 08-JUL-96
Trade Name: AVENTYL HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 014684; Labeling Supplement #: 033 To Original New Drug Application
Approval Date: 08-JUL-96
Trade Name: AVENTYL HCL
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX



Application #: 019885; Labeling Supplement #: 011 To Original New Drug Application
Approval Date: 03-JUL-96
Trade Name: ACCUPRIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE
OTC/RX Status: RX



Application #: 017962; Labeling Supplement #: 051 To Original New Drug Application
Approval Date: 03-JUL-96
Trade Name: PARLODEL
Dosage Form: TABLET; CAPSULE
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): BROMOCRIPTINE MESYLATE
OTC/RX Status: RX

 

 

 

Back to Top     Back to Drug Approvals List

 

Date created: September 30, 1996; last updated: June 20, 2005

horizonal rule