Drug Approvals for August 1996

Definitions and Notes

Original New Drug Applications

Original Application #: 020416
Approval Date: 30-AUG-96
Trade Name: FERIDEX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: ADVANCED MAGNETICS INC
Active Ingredient(s): FERUMOXIDES
OTC/RX Status: RX
Indication(s): ADJUNCT TO MRI (IN ADULT PATIENTS) TO ENHANCE THE T2 WEIGHTED IMAGES USED IN THE DETECTION AND EVALUATION OF LESIONS OF THE LIVER THAT ARE ASSOCIATED WITH AN ALTERATION IN THE RES.

Original Application #: 020508
Approval Date: 29-AUG-96
Trade Name: LAC-HYDRIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CREAM
Applicant: BRISTOL MYERS CO
Active Ingredient(s): AMMONIUM LACTATE
OTC/RX Status: RX
Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS

Original Application #: 020532
Approval Date: 26-AUG-96
Trade Name: IVY BLOCK
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: LOTION
Applicant: ENVIRODERM PHARMACEUTICALS
Active Ingredient(s): BENTOQUATAM
OTC/RX Status: OTC
Indication(s): PROTECTS AGAINST POISON IVY, POISON OAK, AND POISON SUMAC RASH WHEN APPLIED BEFORE CONTACT

Original Application #: 020604
Approval Date: 23-AUG-96
Trade Name: SEROSTIM
Chemical Type: 5
Therapeutic Potential: P
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Indication(s): TREATMENT OF AIDS WASTING ASSOCIATED WITH CATABOLISM WEIGHT LOSS OR CACHEXIA

Original Application #: 020470
Approval Date: 23-AUG-96
Trade Name: CLARITIN-D 24 HOUR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING CORP
Active Ingredient(s): LORATADINE; PSEUDOEPHEDRINE SULFATE
OTC/RX Status: RX
Indication(s): RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS

Original Application #: 050719
Approval Date: 15-AUG-96
Trade Name: HELIDAC THERAPY
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE; TABLET; CAPSULE
Applicant: PROCTER AND GAMBLE CO
Active Ingredient(s): BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): IN COMBINATION WITH AN H2 ANTAGONIST, TREATMENT OF PATIENTS WITH AN ACTIVE DUODENAL ULCER ASSOCIATED WITH HELICOBACTER PYLORI INFECTION

Original Application #: 020627
Approval Date: 15-AUG-96
Trade Name: LEVONORGESTREL IMPLANTS
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: IMPLANT
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX
Indication(s): CONTRACEPTION

Original Application #: 020503
Approval Date: 15-AUG-96
Trade Name: PROVENTIL-HFA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: AEROSOL, METERED
Applicant: 3M PHARMACEUTICALS INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Indication(s): TREATMENT OR PREVENTION OF BRONCHOSPASM IN PATIENTS TWELVE YEARS OF AGE AND OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE

Original Application #: 020640
Approval Date: 09-AUG-96
Trade Name: TAVIST-D
Chemical Type: NEW FORMULATION
Therapeutic Potential: STANDARD REVIEW DRUG
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
OTC/RX Status: OTC
Indication(s): TREATMENT OF ALLERGIC RHINITIS

Original Application #: 020559
Approval Date: 08-AUG-96
Trade Name: TRITEC
Chemical Type:
Therapeutic Potential: STANDARD REVIEW DRUG
Dosage Form: TABLET, FILM COATED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE BISMUTH CITRATE
OTC/RX Status: RX
Indication(s): HEALING AND PREVENTION OF DUODENAL ULCER RELAPSE DUE H PYLORI INFECTION WHEN USE IN CONJUNCTION WITH CLARITHROMYCIN

Original Application #: 020248
Approval Date: 07-AUG-96
Trade Name: INTRALIPID 20%
Chemical Type: NEW FORMULATION
Therapeutic Potential: STANDARD REVIEW DRUG
Dosage Form: BULK
Applicant: PHARMACIA AND UPJOHN INC
Active Ingredient(s): EGG YOLK PHOSPHATIDES; SOYBEAN OIL
OTC/RX Status: RX
Indication(s): SOURCE OF CALORIES AND ESSENTIAL FATTY ACIDS

Original Application #: 020450
Approval Date: 05-AUG-96
Trade Name: CEREBYX
Chemical Type: NEW MOLECULAR ENTITY
Therapeutic Potential: STANDARD REVIEW DRUG
Dosage Form: INJECTION, SOLUTION
Applicant: WARNER LAMBERT CO
Active Ingredient(s): FOSPHENYTOIN SODIUM
OTC/RX Status: RX
Indication(s): TREATMENT OF EPILEPSY

Efficacy Supplemental New Drug Applications

Application #: 019415; Efficacy Supplement #: 009
Type: SE3 to Original New Drug Application
Approval Date: 23-AUG-96
Trade Name: FERTINEX
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC CC
Active Ingredient(s): UROFOLLITROPIN
OTC/RX Status: RX
Efficacy Claim: NEW ROUTE OF ADMINISTRATION--SUBCUTANEOUS

Application #: 020273; Efficacy Supplement #: 001
Type: SE2 to Original New Drug Application
Approval Date: 15-AUG-96
Trade Name: DOVONEX
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CALCIPOTRIENE
OTC/RX Status: RX
Efficacy Claim: CONTINUING SAFETY WHEN USED FOR UP TO ONE YEAR FOR THE TREATMENT OF PLAQUE PSORIASIS

Application #: 020165
Supplement #: 011
Supplement Type: SE6
Approval Date: 02-AUG-96
Trade Name: NICODERM
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): NICOTINE
OTC/RX Status: OTC
Efficacy Claim: Rx to OTC switch

Application #: 019640
Supplement #: 013
Supplement Type: SE1
Approval Date: 01-AUG-96
Trade Name: HUMATROPE
Dosage Form: POWDER, FOR INJECTION SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: Treatment of adult-onset or childhood-onset adult growth hormone deficiency

Approvable Original New Drug Applications

Original Application #: 020592
Approvable Date: 30-AUG-96
Trade Name: ZYPREXA
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): OLANZAPINE
OTC/RX Status: RX

Original Application #: 020587
Approvable Date: 09-AUG-96
Trade Name: SCLEROSOL
Dosage Form: AEROSOL
Applicant: BRYAN CORP
Active Ingredient(s): TALC
OTC/RX Status: RX

Original Application #: 020619
Approvable Date: 01-AUG-96
Trade Name: BETOPTIC PILO
Dosage Form: SUSPENSION, DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074609
Approval Date: 30-AUG-96
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 074607
Approval Date: 30-AUG-96
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 074590
Approval Date: 30-AUG-96
Trade Name: CAPTOPRIL
Dosage Form: TABLET
Applicant: BAKER NORTON PHARMACEUTICALS INC
Active Ingredient(s): CAPTOPRIL
OTC/RX Status: RX

Original Abbreviated Application # 074559
Approval Date: 30-AUG-96
Trade Name: NITROGLYCERIN
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NITROGLYCERIN
OTC/RX Status: RX

Original Abbreviated Application # 074546
Approval Date: 30-AUG-96
Trade Name: CLOZAPINE
Dosage Form: TABLET
Applicant: CREIGHTON PRODUCTS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Original Abbreviated Application # 074531
Approval Date: 30-AUG-96
Trade Name: FLUPHENAZINE DECANOATE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): FLUPHENAZINE DECANOATE
OTC/RX Status: RX

Original Abbreviated Application # 074349
Approval Date: 30-AUG-96
Trade Name: CIMETIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): CIMETIDINE
OTC/RX Status: RX

Original Abbreviated Application # 074229
Approval Date: 30-AUG-96
Trade Name: NADOLOL
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): NADOLOL
OTC/RX Status: RX

Original Abbreviated Application # 040168
Approval Date: 30-AUG-96
Trade Name: HYDROCORTISONE AND ACETIC ACID
Dosage Form: SOLUTION/DROPS
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): HYDROCORTISONE; ACETIC ACID, GLACIAL
OTC/RX Status: RX

Original Abbreviated Application # 020512
Approval Date: 30-AUG-96
Trade Name: 15% CLINISOL
Dosage Form: INJECTABLE
Applicant: CLINTEC NUTRITION CO SUB CLINIQUE
Active Ingredient(s): AMINO ACIDS
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 064065
Approval Date: 28-AUG-96
Trade Name: OTICAIR
Dosage Form: SUSPENSION/DROPS
Applicant: BAUSCH AND LOMB PHARMACEUTICALS INC
Active Ingredient(s): NEOMYCIN SULFATE; POLYMYXIN B SULFATE; HYDROCORTISONE
OTC/RX Status: RX

Original Abbreviated Application # 040102
Approval Date: 28-AUG-96
Trade Name: METHAZOLAMIDE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): METHAZOLAMIDE
OTC/RX Status: RX

Original Abbreviated Application # 040146
Approval Date: 21-AUG-96
Trade Name: FLUPHENAZINE HCL
Dosage Form: ELIXIR
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): FLUPHENAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074698
Approval Date: 20-AUG-96
Trade Name: BACLOFEN
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): BACLOFEN
OTC/RX Status: RX

Original Abbreviated Application # 074584
Approval Date: 19-AUG-96
Trade Name: BACLOFEN
Dosage Form: TABLET
Applicant: ROSEMONT PHARMACEUTICAL CORP
Active Ingredient(s): BACLOFEN
OTC/RX Status: RX

Original Abbreviated Antibiotic Application # 064118
Approval Date: 16-AUG-96
Trade Name: NYSTOP
Dosage Form: POWDER
Applicant: PADDOCK LABORATORIES INC
Active Ingredient(s): NYSTATIN
OTC/RX Status: RX

Original Abbreviated Application # 040126
Approval Date: 16-AUG-96
Trade Name: THIORIDAZINE HCL
Dosage Form: SOLUTION
Applicant: HI TECHNOLOGY PHARMACAL CO INC
Active Ingredient(s): THIORIDAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040125
Approval Date: 16-AUG-96
Trade Name: THIORIDAZINE HCL
Dosage Form: SOLUTION
Applicant: HI TECHNOLOGY PHARMACAL CO INC
Active Ingredient(s): THIORIDAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074562
Approval Date: 15-AUG-96
Trade Name: LO CHOLEST LIGHT
Dosage Form: POWDER
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074561
Approval Date: 15-AUG-96
Trade Name: LO CHOLEST
Dosage Form: POWDER
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074558
Approval Date: 15-AUG-96
Trade Name: LO CHOLEST LIGHT
Dosage Form: POWDER
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074557
Approval Date: 15-AUG-96
Trade Name: LO CHOLEST
Dosage Form: POWDER
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): CHOLESTYRAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074390
Approval Date: 15-AUG-96
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, DELAYED RELEASE
Applicant: GRANUTEC INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 072273
Approval Date: 14-AUG-96
Trade Name: ALBUTEROL
Dosage Form: AEROSOL, METERED
Applicant: ARMSTRONG PHARMACEUTICALS INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX

Original Abbreviated Application #: 074582
Approval Date: 09-AUG-96
Trade Name: DANAZOL
Dosage Form: CAPSULE
Applicant: BARR LABORATORIES INC
Active Ingredient(s): DANAZOL
OTC/RX Status: RX

Original Abbreviated Application #: 040159
Approval Date: 09-AUG-96
Trade Name: MEDROXYPROGESTERONE ACETATE
Dosage Form: TABLET
Applicat: BARR LABORATORIES INC
Active Ingredient(s): MEDROXYPROGESTERONE ACETATE
OTC/RX Status: RX

Original Abbreviated Application #: 040137
Approval Date: 09-AUG-96
Trade Name: CHLORZOXAZONE
Dosage Form: TABLET
Applicat: CHELSEA LABORATORIES INC
Active Ingredient(s): CHLORZOXAZONE
OTC/RX Status: RX

Original Abbreviated Application #: 074641
Approval Date: 02-AUG-96
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicat: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status RX

Original Abbreviated Application #: 074565
Approval Date: 02-AUG-96
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicat: ENDO LABORATORIES LLC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074537
Approval Date: 02-AUG-96
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicat: NOVOPHARM LTD
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074147
Approval Date: 02-AUG-96
Trade Name: METOCLOPRAMIDE HCL
Dosage Form: INJECTION
Applicat: SANOFI WINTHROP INC
Active Ingredient(s): METOCLOPRAMIDE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074072
Approval Date: 01-AUG-96
Trade Name: ALBUTEROL
Dosage Form: AEROSOL, METERED
Applicat: MEDISOL LABORATORIES INC
Active Ingredient(s): ALBUTEROL
OTC/RX Status: RX

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

Original Abbreviated Application #: 074570
Tentative Approval Date: 30-AUG-96
Trade Name: ACYCLOVIR
Dosage Form: CAPSULE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application #: 074635
Tentative Approval Date: 20-AUG-96
Trade Name: NAPROXEN SODIUM
Dosage Form: TABLET
Applicant: NOVOPHARM LTD
Active Ingredient(s): NAPROXEN SODIUM
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 019651 Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 30-AUG-96
Trade Name: ASACOL
Dosage Form: TABLET, DELAYED RELEASE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 020180; Labeling Supplement #: 011 To Original New Drug Application
Approval Date: 28-AUG-96
Trade Name: PROSCAR
Dosage Form: TABLET
Applicant: MERCK SHARP AND DOHME RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): FINASTERIDE
OTC/RX Status: RX

Application #: 015923 Labeling Supplement #: 054 To Original New Drug Application
Approval Date: 28-AUG-96
Trade Name: HALDOL
Dosage Form: INJECTABLE
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP
Active Ingredient(s): HALOPERIDOL LACTATE
OTC/RX Status: RX

Application #: 050486 Labeling Supplement #: 013 To Original New Drug Application
Approval Date: 27-AUG-96
Trade Name: VIRA-A
Dosage Form: OINTMENT
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): VIDARABINE
OTC/RX Status: RX

Application #: 050201 Labeling Supplement #: 026 To Original New Drug Application
Approval Date: 27-AUG-96
Trade Name: OPHTHOCORT
Dosage Form: OINTMENT
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): CHLORAMPHENICOL; POLYMYXIN B SULFATE; HYDROCORTISONE ACETATE
OTC/RX Status: RX

Application #: 019779 Labeling Supplement #: 010 To Original New Drug Application
Approval Date: 27-AUG-96
Trade Name: IOPIDINE
Dosage Form: SOLUTION/DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): APRACLONIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019264; Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 27-AUG-96
Trade Name: PENTAM
Dosage Form: INJECTABLE
Applicant: FUJISAWA USA INC
Active Ingredient(s): PENTAMIDINE ISETHIONATE
OTC/RX Status: RX

Application #: 018511; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 23-AUG-96
Trade Name: DTPA
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): TECHNETIUM TC-99M PENTETATE KIT
OTC/RX Status: RX

Application #: 018035; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 23-AUG-96
Trade Name: TECHNESCAN MDP KIT
Dosage Form: INJECTABLE
Applicant: MERCK SHARP AND DOHME DIV MERCK AND CO INC
Active Ingredient(s): TECHNETIUM TC-99M MEDRONATE KIT
OTC/RX Status: RX

Application #: 050646; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: CEPTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME (ARGININE FORMULATION)
OTC/RX Status: RX

Application #: 050634; Labeling Supplement #: 005 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME SODIUM
OTC/RX Status: RX

Application #: 050578; Labeling Supplement #: 031 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: FORTAZ
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFTAZIDIME
OTC/RX Status: RX

Application #: 050632; Labeling Supplement #: 007 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX

Application #: 050632; Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX

Application #: 050580; Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX

Application #: 050580; Labeling Supplement #: 021 To Original New Drug Application
Approval Date: 20-AUG-96
Trade Name: AZACTAM
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): AZTREONAM
OTC/RX Status: RX

Application #: 020392; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 16-AUG-96
Trade Name: CYSTAGON
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CYSTEAMINE BITARTRATE
OTC/RX Status: RX

Application #: 050143; Labeling Supplement #: 016 To Original New Drug Application
Approval Date: 14-AUG-96
Trade Name: CHLOROMYCETIN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): CHLORAMPHENICOL
OTC/RX Status: RX

Application #: 020474; Labeling Supplement #: 002 To Original New Drug Application
Approval Date: 14-AUG-96
Trade Name: VEXOL
Dosage Form: SUSPENSION, DROPS
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): RIMEXOLONE
OTC/RX Status: RX

Application #: 020219; Labeling Supplement #: 004 To Original New Drug Application
Approval Date: 14-AUG-96
Trade Name: LIVOSTIN
Dosage Form: SUSPENSION/DROPS
Applicant: CIBA VISION OPHTHALMICS DIV CIBA VISION CORP
Active Ingredient(s): LEVOCABASTINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050625; Labeling Supplement #: 023 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: SANDIMMUNE
Dosage Form: CAPSULE
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050574; Labeling Supplement #: 018 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: SANDIMMUNE
Dosage Form: SOLUTION
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 050573; Labeling Supplement #: 012 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: SANDIMMUNE
Dosage Form: INJECTABLE
Applicant: SANDOZ PHARMACEUTICALS CORP DIV SANDOZ INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 019858; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019857; Labeling Supplement #: 016 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019847; Labeling Supplement #: 014 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: CIPRO
Dosage Form: INJECTABLE
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN
OTC/RX Status: RX

Application #: 019810; Labeling Supplement #: 041 To Original New Drug Application
Approval Date: 09-AUG-96
Trade Name: PRILOSEC
Dosage Form: CAPSULE, DELAYED RELEASE PELLETS
Applicant: ASTRA MERCK INC
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Application #: 020090; Labeling Supplement #: 008 To Original New Drug Application
Approval Date: 06-AUG-96
Trade Name: DIFLUCAN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: PFIZER CHEMICALS DIV PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019950; Labeling Supplement #: 024 To Original New Drug Application
Approval Date: 06-AUG-96
Trade Name: DIFLUCAN
Dosage Form: INJECTION
Applicant: PFIZER INC
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019949; Labeling Supplement #: 022 To Original New Drug Application
Approval Date: 06-AUG-96
Trade Name: DIFLUCAN
Dosage Form: TABLET
Applicant: PFIZER CENTRAL RESEARCH
Active Ingredient(s): FLUCONAZOLE
OTC/RX Status: RX

Application #: 019640; Labeling Supplement #: 017 To Original New Drug Application
Approval Date: 05-AUG-96
Trade Name: HUMATROPE
Dosage Form: POWDER, FOR INJECTION SOLUTION
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX

Application #: 017407; Labeling Supplement #: 028 To Original New Drug Application
Approval Date: 02-AUG-96
Trade Name: CATAPRES
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM
Active Ingredient(s): CLONIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017407; Labeling Supplement #: 027 To Original New Drug Application
Approval Date: 02-AUG-96
Trade Name: CATAPRES
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM
Active Ingredient(s): CLONIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 008678; Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 01-AUG-96
Trade Name: ISONIAZID
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): ISONIAZID
OTC/RX Status: RX