Drug Approvals for June 1997

Definitions and Notes

June 1997

Original New Drug Applications

Original Application #: 020729
Approval Date: 27-JUN-97
Trade Name: UNIRETIC
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of patients with hypertension (the fixed combination is not indicated for the initial therapy of hypertension)

Original Application #: 020740
Approval Date: 26-JUN-97
Trade Name: BAYCOL
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX
Indication(s): Adjunct to diet for the reduction of elevated total and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Frederickson Types IIa and IIb) when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate

Original Application #: 020606
Approval Date: 26-JUN-97
Trade Name: IMODIUM ADVANCED
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET, CHEWABLE
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
OTC/RX Status: OTC
Indication(s): For control of the symptoms of diarrhea plus bloating, pressure and cramps commonly referred to as gas

Original Application #: 020710
Approval Date: 25-JUN-97
Trade Name: PAXIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of depression

Original Application #: 020441
Approval Date: 24-JUN-97
Trade Name: PULMICORT TURBUHALER
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: AEROSOL, METERED
Applicant: ASTRA SCIENTIFIC
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Indication(s): Maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older and for patients requiring oral corticosteroid therapy for asthma

Original Application #: 020689
Approval Date: 20-JUN-97
Trade Name: POSICOR
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MIBEFRADIL DIHYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of hypertension and chronic stable angina pectoris

Original Application #: 050738
Approval Date: 19-JUN-97
Trade Name: NEORAL
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Indication(s): Treatment of severe recalcitrant psoriasis

Original Application #: 050737
Approval Date: 19-JUN-97
Trade Name: NEORAL
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CAPSULE, SOFT GELATIN
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Indication(s): Treatment of severe recalcitrant psoriasis

Original Application #: 050723
Approval Date: 19-JUN-97
Trade Name: CELLCEPT
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: ROCHE BIOSCIENCE
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Indication(s): For the prophylaxis of organ rejection in patients receiving allogeneic renal transplants

Original Application #: 020877
Approval Date: 17-JUN-97
Trade Name: PREVACID
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CAPSULE, DELAYED REL GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Indication(s): For the use of lansoprazole in combination with amoxicillin for the eradication of Helicobacter pylori in patients with active duodenal ulcer disease or a one-year history of a duodenal ulcer

Original Application #: 020876
Approval Date: 17-JUN-97
Trade Name: PREVACID
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: CAPSULE, DELAYED REL GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Indication(s): For the use of lansoprazole in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with active duodenal ulcer disease or a one-year history of a duodenal ulcer

Original Application #: 020600
Approval Date: 13-JUN-97
Trade Name: TAZORAC
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: GEL
Applicant: ALLERGAN INC
Active Ingredient(s): TAZAROTENE
OTC/RX Status: RX
Indication(s): For the topical treatment of patients with stable plaque psoriasis of up to 20% body surface area involvement and topical treatment of patients with facial acne vulgaris of mild to moderate severity

Original Application #: 020649
Approval Date: 12-JUN-97
Trade Name: EDEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Indication(s): For the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology

Efficacy Supplemental New Drug Applications

Application #: 019726 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 27-JUN-97
Trade Name: ZOLADEX
Dosage Form: IMPLANT
Applicant: ZENECA PHARMACEUTICALS DIV ZENECA INC
Active Ingredient(s): GOSERELIN ACETATE
OTC/RX Status: RX
Efficacy Claim: Endometrial thinning agent prior to endometrial ablation for dysfunctional uterine bleeding

Application #: 019773 Efficacy Supplement #: 008
Type: SE1 to Original New Drug Application
Approval Date: 16-JUN-97
Trade Name: VENTOLIN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Efficacy Claim: For the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm

Application #: 019269 Efficacy Supplement #: 014
Type: SE1 to Original New Drug Application
Approval Date: 16-JUN-97
Trade Name: VENTOLIN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Efficacy Claim: For the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm

Application #: 019537 Efficacy Supplement#: 029
Type: SE1 to Original New Drug Application
Approval Date: 03-JUN-97
Trade Name: CIPRO
Dosage Form: TABLET
Applicant: BAYER CORP
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute sinusitis

Approvable Original New Drug Applications

Original Application #: 020739
Approvable Date: 20-JUN-97
Trade Name: LIVOSTIN
Dosage Form: SPRAY
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): LEVOCABASTINE HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020792
Approvable Date: 19-JUN-97
Trade Name: CARDIZEM MONOVIAL
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020644
Approvable Date: 16-JUN-97
Trade Name: SERLECT
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): SERTINDOLE
OTC/RX Status: RX

Original Application #: 020689
Approvable Date: 11-JUN-97
Trade Name: POSICOR
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): MIBEFRADIL DIHYDROCHLORIDE
OTC/RX Status: RX

Original Application #: 020812
Approvable Date: 06-JUN-97
Trade Name: ADVIL
Dosage Form: SUSPENSION
Applicant: WHITEHALL ROBINS HEALTHCARE
Active Ingredient(s): IBUPROFEN
OTC/RX Status: OTC

Original Application #: 020697
Approvable Date: 05-JUN-97
Trade Name: TASMAR
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): TOLCAPONE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 074835
Approval Date: 30-JUN-97
Trade Name: NORTRIPTYLINE HCL
Dosage Form: CAPSULE
Applicant: INVAMED INC
Active Ingredient(s): NORTRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064171
Approval Date: 30-JUN-97
Trade Name: PAROM0MYCIN SULFATE
Dosage Form: CAPSULE
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): PAROMOMYCIN SULFATE
OTC/RX Status: RX

Original Abbreviated Application # 040186
Approval Date: 30-JUN-97
Trade Name: MEPERIDINE HCL
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): MEPERIDINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040136
Approval Date: 30-JUN-97
Trade Name: HYDRALAZINE HCL
Dosage Form: INJECTABLE
Applicant: LUITPOLD PHARMACEUTICALS INC
Active Ingredient(s): HYDRALAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074841
Approval Date: 27-JUN-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: ENDO LABORATORIES LLC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX

Original Abbreviated Application # 074790
Approval Date: 26-JUN-97
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 040090
Approval Date: 26-JUN-97
Trade Name: ISONIAZID
Dosage Form: TABLET
Applicant: MIKART INC
Active Ingredient(s): ISONIAZID
OTC/RX Status: RX

Original Abbreviated Application # 074953
Approval Date: 25-JUN-97
Trade Name: CLOMIPRAMINE HCL
Dosage Form: CAPSULE
Applicant: INVAMED INC
Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074762
Approval Date: 25-JUN-97
Trade Name: GUANFACINE HCL
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): GUANFACINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074459
Approval Date: 25-JUN-97
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET, DELAYED RELEASE
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 040147
Approval Date: 25-JUN-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Application # 040099
Approval Date: 25-JUN-97
Trade Name: LORTAB
Dosage Form: TABLET
Applicant: UCB PHARMA INC
Active Ingredient(s): ACETAMINOPHEN; HYDROCODONE BITARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 074598
Approval Date: 19-JUN-97
Trade Name: HYDROMORPHONE HCL
Dosage Form: INJECTABLE
Applicant: SANOFI WINTHROP INC
Active Ingredient(s): HYDROMORPHONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040228
Approval Date: 19-JUN-97
Trade Name: PHENTERMINE HCL
Dosage Form: CAPSULE
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040227
Approval Date: 18-JUN-97
Trade Name: PHENTERMINE HCL
Dosage Form: CAPSULE
Applicant: AMIDE PHARMACEUTICALS INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 040174
Approval Date: 12-JUN-97
Trade Name: LEUCOVORIN CALCIUM
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): LEUCOVORIN CALCIUM
OTC/RX Status: RX

Original Abbreviated Application # 074784
Approval Date: 11-JUN-97
Trade Name: ATRACURIUM BESYLATE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): ATRACURIUM BESYLATE
OTC/RX Status: RX

Original Abbreviated Application # 074871
Approval Date: 06-JUN-97
Trade Name: SELEGILINE HCL
Dosage Form: TABLET
Applicant: APOTEX USA INC
Active Ingredient(s): SELEGILINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074870
Approval Date: 05-JUN-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Original Abbreviated Application # 074821
Approval Date: 05-JUN-97
Trade Name: TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TRIAMTERENE
OTC/RX Status: RX

Original Abbreviated Application # 074802
Approval Date: 05-JUN-97
Trade Name: KETORALAC TROMETHAMINE
Dosage Form: INJECTABLE (vial)
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Application # 074801
Approval Date: 05-JUN-97
Trade Name: KETORALAC TROMETHAMINE
Dosage Form: INJECTABLE (syringe)
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application# 064159
Approval Date: 05-JUN-97
Trade Name: CLINDAMYCIN PHOSPHATE
Dosage Form: SOLUTION
Applicant: E FOUGERA DIV ALTANA INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 074662
Tentative Approval Date: 17-JUN-97
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074488
Tentative Approval Date: 17-JUN-97
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: GRANUTEC INC
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 074315
Tentative Approval Date: 17-JUN-97
Trade Name: TERAZOSIN HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 074023
Tentative Approval Date: 17-JUN-97
Trade Name: RANITIDINE
Dosage Form: TABLET
Applicant: GENPHARM INC PHARMACEUTICALS
Active Ingredient(s): RANITIDINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 050630 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 30-JUN-97
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

Application #: 050587 Labeling Supplement #: 047
To Original New Drug Application
Approval Date: 30-JUN-97
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

Application #:020665Labeling Supplement#:001
To Original New Drug Application
Approval Date: 27-JUN-97
Trade Name: DIOVAN
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): VALSARTAN
OTC/RX Status: RX

Application #:019758Labeling Supplement#:032
To Original New Drug Application
Approval Date: 27-JUN-97
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #:019261Labeling Supplement#:005
To Original New Drug Application
Approval Date: 25-JUN-97
Trade Name: PAREMYD
Dosage Form: SOLUTION/DROPS
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE
OTC/RX Status: RX

Application #: 020406 Labeling Supplement #: 018
To Original New Drug Application
Approval Date: 23-JUN-97
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED REL GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX

Application #: 019384 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 20-JUN-97
Trade Name: NOROXIN
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): NORFLOXACIN
OTC/RX Status: RX

Application #: 016708 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 20-JUN-97
Trade Name: SODIUM CHROMATE CR 51
Dosage Form: INJECTABLE
Applicant: MALLINCKRODT MEDICAL INC
Active Ingredient(s): SODIUM CHROMATE, CR-51
OTC/RX Status: RX

Application #:050716Labeling Supplement#:004
To Original New Drug Application
Approval Date: 19-JUN-97
Trade Name: NEORAL
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICAL CORPORATION
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #: 020092 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 19-JUN-97
Trade Name: DILACOR XR
Dosage Form: CAPSULE
Applicant: RHONE POULENC RORER PHARMACEUTICALS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #:050715Labeling Supplement#:004
To Original New Drug Application
Approval Date: 19-JUN-97
Trade Name: NEORAL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICAL CORPORATION
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX

Application #:017831Labeling Supplement#:051
To Original New Drug Application
Approval Date: 18-JUN-97
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 #: 017395 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 17-JUN-97
Trade Name: INTROPIN
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020406 Labeling Supplement #: 015 To Original New Drug Application
Approval Date: 17-JUN-97
Trade Name: PREVACID
Dosage Form: CAPSULE, DELAYED RELEASE GRANULES
Applicant: TAP HOLDINGS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX

Application #:017831Labeling Supplement#:050
To Original New Drug Application
Approval Date: 16-JUN-97
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 #: 018771 Labeling Supplement #: 009 To Original New Drug Application
Approval Date: 15-JUN-97
Trade Name: LACRISERT
Dosage Form: INSERT
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): HYDROXYPROPYL CELLULOSE
OTC/RX Status: RX

Application #: 050557 Labeling Supplement #: 019 To Original New Drug Application
Approval Date: 11-JUN-97
Trade Name: BENZAMYCIN
Dosage Form: GEL
Applicant: DERMIK LABORATORIES INC
Active Ingredient(s): ERYTHROMYCIN-BENZOYL PEROXIDE
OTC/RX Status: RX

Application #: 019309 Labeling Supplement #: 021 To Original New Drug Application
Approval Date: 11-JUN-97
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 #: 023 To Original New Drug Application
Approval Date: 11-JUN-97
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 #: 019099 Labeling Supplement #: 006 To Original New Drug Application
Approval Date: 11-JUN-97
Trade Name: DOPAMINE HCL AND DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: MCGAW INC
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018998 Labeling Supplement #: 053 To Original New Drug Application
Approval Date: 11-JUN-97
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 #: 019821 Labeling Supplement #: 001 To Original New Drug Application
Approval Date: 05-JUN-97
Trade Name: SORIATANE
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): ACITRETIN
OTC/RX Status: RX

Application #: 017576 Labeling Supplement#:046 To Original New Drug Application
Approval Date: 05-JUN-97
Trade Name: OVCON-50
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NORETHINDRONE; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 050672 Labeling Supplement #: 010 To Original New Drug Application
Approval Date: 04-JUN-97
Trade Name: CEFTIN
Dosage Form: POWDER, FOR RECONSTITUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX

Application #: 050605 Labeling Supplement #: 027 To Original New Drug Application
Approval Date: 04-JUN-97
Trade Name: CEFTIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME AXETIL
OTC/RX Status: RX