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Drug Approvals for October 1997
Definitions and Notes
October 1997
Original New Drug Applications
Original Application #: 020755
Approval Date: 31-OCT-97
Trade Name: CAVERJECT
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Indication(s): Provides for an aqueous formulation for the treatment of erectile dysfunction due to neurogenic, vasculogenic, psychogenic, or mixed etiology; as an adjunct to other diagnostic tests in the diagnostic of erectile dysfunction
Original Application #: 020699
Approval Date: 20-OCT-97
Trade Name: EFFEXOR XR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Treatment of depression
Original Application #: 020749
Approval Date: 17-OCT-97
Trade Name: LAMISIL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum ovale), and tinea pedis (athlete's foot), tinea cruris (jock itch), or tinea corporis (ringworm), due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum
Original Application #: 020292
Approval Date: 14-OCT-97
Trade Name: FERRISELTZ
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: POWDER, FOR ORAL SOLUTION
Applicant: ONCOMEMBRANE INC
Active Ingredient(s): FERRIC AMMONIUM CITRATE
OTC/RX Status: RX
Indication(s): For use with T1-weighted magnetic resonance imaging (MRI) to enhance the delineation of the bowel to distinguish it from organs and tissues that are adjacent to the upper regions of the gastrointestinal tract
Original Application #: 020310
Approval Date: 10-OCT-97
Trade Name: NIZORAL A-D
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SHAMPOO
Applicant: JOHNSON AND JOHNSON CONSUMER PRODUCTS INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: OTC
Indication(s): Control of flaking, scaling, and itching associated with dandruff
Original Application #: 020762
Approval Date: 01-OCT-97
Trade Name: NASONEX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SPRAY, METERED
Applicant: SCHERING PLOUGH CORP
Active Ingredient(s): MOMETASONE FUROATE
OTC/RX Status: RX
Indication(s): Prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and the treatment of the nasal symptoms of perennial allergic rhinitis, in adults and children 12 years of age and older
Original Application #: 020750
Approval Date: 01-OCT-97
Trade Name: TILADE
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: RHONE POULENC RORER CENTRAL RESEARCH
Active Ingredient(s): NEDOCROMIL SODIUM
OTC/RX Status: RX
Indication(s): Maintenance therapy in the management of mild-to-moderate asthma in patients two years of age and older
Efficacy Supplemental New Drug Applications
Application #: 020280 Efficacy Supplement#: 008
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: GENOTROPIN
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Efficacy Claim: For long-term replacement therapy in adults with growth hormone deficiency as demonstrated by an appropriate GH stimulation test
Application #:020007 Efficacy Supplement#:022
Type: SE3 to Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For intramuscular administration as an alternative to intravenous administration in the prevention of postoperative nausea and vomiting
Application #: 019766 Efficacy Supplement#: 021
Type: SE1 to Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: ZOCOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s ): SIMVASTATIN
OTC/RX Status: RX
Efficacy Claim: Labeling revision(s) not specified in approval letter
Application #: 020640 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: TAVIST-D
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLEMASTINE FUMARATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
OTC/RX Status: OTC
Efficacy Claim: Treatment of common cold symptoms
Application #: 020588 Efficacy Supplement#: 002
Type: SE2 to Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: RISPERDAL
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): RISPERIDONE
OTC/RX Status: RX
Efficacy Claim: Provide for the administration in either a once daily(QD), or twice daily(BID) dosing regimen
Application #: 020272 Efficacy Supplement#: 007
Type: SE2 to Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: RISPERDAL
Dosage Form: TABLET
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): RISPERIDONE
OTC/RX Status: RX
Efficacy Claim: Provide for the administration in either a once daily(QD), or twice daily(BID) dosing regimen
Application #: 020351 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: VISIPAQUE 270
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): IODIXANOL
OTC/RX Status: RX
Efficacy Claim: For pediatric population
Application #: 019839 Efficacy Supplement#: 017
Type: SE5 to Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: Treatment of obsessive compulsive disorder in the pediatric population
Application #: 017618 Efficacy Supplement#: 036
Type: SE5 to Original New Drug Application
Approval Date: 08-OCT-97
Trade Name: BRICANYL
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): TERBUTALINE SULFATE
OTC/RX Status: RX
Efficacy Claim: For the relief of reversible bronchospasm in patients 6 years of age and older
Application #: 017466 Efficacy Supplement#: 024
Type: SE5 to Original New Drug Application
Approval Date: 08-OCT-97
Trade Name: BRICANYL
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): TERBUTALINE SULFATE
OTC/RX Status: RX
Efficacy Claim: For the relief of reversible bronchospasm in patients 6 years of age and older
Application #: 020305 Efficacy Supplement#: 001
Type: SE2 to Original New Drug Application
Approval Date: 06-OCT-97
Trade Name: KYTRIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): GRANISETRON HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For a single 2mg dose as an alternative to the 1mg dose given twice daily
Application #: 050519 Efficacy Supplement#: 022
Type: SE5 to Original New Drug Application
Approval Date: 01-OCT-97
Trade Name: NEBCIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): TOBRAMYCIN SULFATE
OTC/RX Status: RX
Efficacy Claim: For specific dosing of patients with cystic fibrosis
Application #:050477Efficacy Supplement#:021
Type: SE5 to Original New Drug Application
Approval Date: 01-OCT-97
Trade Name: NEBCIN
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): TOBRAMYCIN SULFATE
OTC/RX Status: RX
Efficacy Claim: For specific dosing of patients with cystic fibrosis
Application #:020261Efficacy Supplement#:012
Type: SE1 to Original New Drug Application
Approval Date: 01-OCT-97
Trade Name: LESCOL
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FLUVASTATIN SODIUM
OTC/RX Status: RX
Efficacy Claim: To slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels
Approvable Original New Drug Applications
Original Application #: 020746
Approvable Date: 29-OCT-97
Trade Name: RHINOCORT AQUA
Dosage Form: SPRAY
Applicant: ASTRA SCIENTIFIC
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Original Application #: 020839
Approvable Date: 27-OCT-97
Trade Name: PLAVIX
Dosage Form: TABLET
Applicant: SANOFI PHARMACEUTICALS INC
Active Ingredient(s): CLOPIDOGREL BISULFATE
OTC/RX Status: RX
Original Application #: 020587
Approvable Date: 27-OCT-97
Trade Name: SCLEROSOL INTRAPLEURAL AEROSOL
Dosage Form: AEROSOL
Applicant: BRYAN CORP
Active Ingredient(s): STERILE TALC POWDER
OTC/RX Status: RX
Original Application #: 020738
Approvable Date: 10-OCT-97
Trade Name: TEVETEN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): EPROSARTAN MESYLATE
OTC/RX Status: RX
Original Application #: 020120
Approvable Date: 09-OCT-97
Trade Name: TRI-NASAL
Dosage Form: SPRAY
Applicant: MURO PHARMACEUTICAL INC
Active Ingredient(s): TRIAMCINOLONE ACETONIDE
OTC/RX Status: RX
Original Abbreviated New Drug Applications
Original Abbreviated Application # 075079
Approval Date: 31-OCT-97
Trade Name: OXYBUTYNIN CHLORIDE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075027
Approval Date: 31-OCT-97
Trade Name: CLOBETASOL PROPIONATE
Dosage Form: GEL
Applicant: STIEFEL LABORATORIES INC
Active Ingredient(s): CLOBETASOL PROPIONATE
OTC/RX Status: RX
Original Abbreviated Application # 074891
Approval Date: 31-OCT-97
Trade Name: ACYCLOVIR
Dosage Form: TABLET
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX
Original Abbreviated Application # 074703
Approval Date: 31-OCT-97
Trade Name: METOCLOPRAMIDE
Dosage Form: SOLUTION
Applicant: JVL CORP
Active Ingredient(s): METOCLOPRAMIDE
OTC/RX Status: RX
Original Abbreviated Application # 040194
Approval Date: 31-OCT-97
Trade Name: METHYLPREDNISOLONE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): METHYLPREDNISOLONE
OTC/RX Status: RX
Original Abbreviated Application # 040189
Approval Date: 31-OCT-97
Trade Name: METHYLPREDNISOLONE
Dosage Form: TABLET
Applicant: TRIGEN LABORATORIES INC
Active Ingredient(s): METHYLPREDNISOLONE
OTC/RX Status: RX
Original Abbreviated Application # 074940
Approval Date: 30-OCT-97
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: ALPHAPHARM PARTY LTD
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 074927
Approval Date: 30-OCT-97
Trade Name: ETODOLAC
Dosage Form: TABLET
Applicant: AESGEN INC
Active Ingredient(s): ETODOLAC
OTC/RX Status: RX
Original Abbreviated Application # 074160
Approval Date: 30-OCT-97
Trade Name: BUMETANIDE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): BUMETANIDE
OTC/RX Status: RX
Original Abbreviated Application # 040234
Approval Date: 30-OCT-97
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: CAPSULE
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040171
Approval Date: 30-OCT-97
Trade Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form: TABLET
Applicant: ROYCE LABORATORIES INC
Active Ingredient(s): ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074664
Approval Date: 28-OCT-97
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: HI TECH PHARMACAL CO INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074655
Approval Date: 22-OCT-97
Trade Name: RANITIDINE HCL
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040197
Approval Date: 22-OCT-97
Trade Name: ESTRADIOL
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Original Abbreviated Application # 074864
Approval Date: 20-OCT-97
Trade Name: RANITIDINE HCL
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074645
Approval Date: 20-OCT-97
Trade Name: NICOTINE
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: SANO CORP
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Original Abbreviated Application # 074612
Approval Date: 20-OCT-97
Trade Name: NICOTINE
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: SANO CORP
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Original Abbreviated Application # 074611
Approval Date: 20-OCT-97
Trade Name: NICOTINE
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: SANO CORP
Active Ingredient(s): NICOTINE
OTC/RX Status: RX
Original Abbreviated Application # 074757
Approval Date: 17-OCT-97
Trade Name: CIMETIDINE HCL
Dosage Form: SOLUTION
Applicant: MORTON GROVE PHARMACEUTICALS INC
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040232
Approval Date: 16-OCT-97
Trade Name: METHYLPREDNISOLONE
Dosage Form: TABLET
Applicant: CHELSEA LABORATORIES INC
Active Ingredient(s): METHYLPREDNISOLONE
OTC/RX Status: RX
Original Abbreviated Application # 074997
Approval Date: 15-OCT-97
Trade Name: OXYBUTYNIN CHLORIDE
Dosage Form: SYRUP
Applicant: NUPHARM INC
Active Ingredient(s): OXYBUTYNIN CHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 074913
Approval Date: 15-OCT-97
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 074888
Approval Date: 15-OCT-97
Trade Name: DESMOPRESSIN ACETATE
Dosage Form: INJECTABLE
Applicant: GENSIA LABORATORIES LTD
Active Ingredient(s): DESMOPRESSIN ACETATE
OTC/RX Status: RX
Original Abbreviated Application # 074852
Approval Date: 10-OCT-97
Trade Name: DILTIAZEM HCL
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: ANDRX PHARM
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064166
Approval Date: 02-OCT-97
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064165
Approval Date: 02-OCT-97
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064164
Approval Date: 02-OCT-97
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 064155
Approval Date: 02-OCT-97
Trade Name: CEFACLOR
Dosage Form: SUSPENSION
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Approvals with Tentative Approval
Original Abbreviated Application #: 074832
Tentative Approval Date: 10-OCT-97
Trade Name: CAPTOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): CAPTOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020403 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: ZOFRAN
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ONDANSETRON HYDROCHLORIDE
OTC/RX Status: RX
Application #: 011355 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 31-OCT-97
Trade Name: ENDRATE
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): EDETATE DISODIUM
OTC/RX Status: RX
Application #: 019773 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 30-OCT-97
Trade Name: VENTOLIN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 019621 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 30-OCT-97
Trade Name: VENTOLIN
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 019489 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 30-OCT-97
Trade Name: VENTOLIN ROTACAPS
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 019269 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 30-OCT-97
Trade Name: VENTOLIN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 019112 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 30-OCT-97
Trade Name: VENTOLIN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 020702 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 28-OCT-97
Trade Name: LIPITOR
Dosage Form: TABLET
Applicant: PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
Active Ingredient(s): ATORVASTATIN CALCIUM
OTC/RX Status: RX
Application #: 019309 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 27-OCT-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 #: 018397 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 20-OCT-97
Trade Name: CHLOR-TRIMETON
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
OTC/RX Status: OTC
Application #: 007638 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 20-OCT-97
Trade Name: CHLOR-TRIMETON
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: SCHERING PLOUGH HEALTHCARE PRODUCTS INC
Active Ingredient(s): CHLORPHENIRAMINE MALEATE
OTC/RX Status: OTC
Application #: 020624 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: ANZEMET
Dosage Form: INJECTABLE
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE
OTC/RX Status: RX
Application #: 020623 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: ANZEMET
Dosage Form: TABLET
Applicant: HOECHST MARION ROUSSEL INC
Active Ingredient(s): DOLASETRON MESYLATE
OTC/RX Status: RX
Application #: 018299 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-OCT-97
Trade Name: VIROPTIC
Dosage Form: SOLUTION/DROPS
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): TRIFLURIDINE
OTC/RX Status: RX
Application #: 020548 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 14-OCT-97
Trade Name: FLOVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX
Application #: 020351 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: VISIPAQUE 270
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): IODIXANOL
OTC/RX Status: RX
Application #: 019839 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017352 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: FASTIN
Dosage Form: CAPSULE
Applicant: SMITHKLINE BEECHAM
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 013993 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 10-OCT-97
Trade Name: CHROMITOPE SODIUM
Dosage Form: INJECTABLE
Applicant: BRACCO DIAGNOSTICS INC
Active Ingredient(s): SODIUM CHROMATE, CR-51
OTC/RX Status: RX
Application #: 020147 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 09-OCT-97
Trade Name: TRAVASOL SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE;
OTC/RX Status: RX
Application #: 020379 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 08-OCT-97
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Application #: 019604 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 08-OCT-97
Trade Name: VOLMAX
Dosage Form: TABLET
Applicant: MURO PHARMACEUTICALS, INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Application #: 020123 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 03-OCT-97
Trade Name: OMNISCAN
Dosage Form: INJECTABLE
Applicant: NYCOMED INC
Active Ingredient(s): GADODIAMIDE
OTC/RX Status: RX
Application #: 019640 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 03-OCT-97
Trade Name: HUMATROPE
Dosage Form: INJECTABLE
Applicant: ELI LILLY AND CO
Active Ingredient(s): SOMATROPIN, BIOSYNTHETIC
OTC/RX Status: RX
Application #: 020685 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 01-OCT-97
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK AND CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX
Application #: 020401 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 01-OCT-97
Trade Name: TIAZAC
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX
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Date created: December 22, 1997; last updated: June 20, 2005 |
