Drug Approvals for July 1996

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