Drug Approvals for October 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021356
Approval Date: 26-OCT-01
Trade Name: VIREAD
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GILEAD SCIENCES INC
Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE
OTC/RX Status: RX
Indication(s): For use in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults

Original Application #: 021317
Approval Date: 18-OCT-01
Trade Name: BAYER EXTRA STRENGTH ASPIRIN
Chemical Type:
Therapeutic Potential:
Dosage Form: TABLET
Applicant: BAYER CORPORATION
Active Ingredient(s): For the use of Bayer Extra Strength Aspirin for Migraine Pain

Original Application #: 021303
Approval Date: 11-OCT-01
Trade Name: ADDERALL XR
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: SHIRE LABORATORIES INC
Active Ingredient(s): AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Indication(s): For the treatment of Attention Deficit Hyperactivity Disorder

Original Application #: 021187
Approval Date: 03-OCT-01
Trade Name: NUVARING
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: SPONGE
Applicant: ORGANON INC
Active Ingredient(s): ETHINYL ESTRADIOL; ETONOGESTREL
OTC/RX Status: RX
Indication(s): For the prevention of pregnancy in women who elect to use this product as a method of contraception

Original Application #: 021324
Approval Date: 02-OCT-01
Trade Name: ENTOCORT EC
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Indication(s): For the treatment of mild to moderate active Crohn's Disease involving the ileum and/or ascending colon

Efficacy Supplemental New Drug Applications

Application #: 020746 Efficacy Supplement#: 004
Type: SE8 to Original New Drug Application
Approval Date: 26-OCT-01
Trade Name: RHINOCORT AQUA
Dosage Form: SPRAY
Applicant: ASTRAZENECA LP
Active Ingredient(s): BUDESONIDE
OTC/RX Status: RX
Efficacy Claim: For the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older

Application #: 020988 Efficacy Supplement#: 003
Type: SE1 to Original New Drug Application
Approval Date: 19-OCT-01
Trade Name: PROTONIX IV
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Efficacy Claim: For the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES)

Application #: 020998 Efficacy Supplement#: 010
Type: SE1 to Original New Drug Application
Approval Date: 18-OCT-01
Trade Name: CELEBREX
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): CELECOXIB
OTC/RX Status: RX
Efficacy Claim: For the management of acute pain in adults and the treatment of primary dysmenorrhea

Application #: 021062 Efficacy Supplement#: 008
Type: SE2 to Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX
Efficacy Claim: For the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration

Application #: 021061 Efficacy Supplement#: 007
Type: SE2 to Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX
Efficacy Claim:For the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration

Application #: 020990 Efficacy Supplement#: 001
Type: SE8 to Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: ZOLOFT
Dosage Form: CONCENTRATE
Applicant: PFIZER PHARMACEUTICALS
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of pediatric obsessive compulsive disorder (OCD)

Application #: 019839 Efficacy Supplement#: 033
Type: SE8 to Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of pediatric obsessive compulsive disorder (OCD)

Application #: 021184 Efficacy Supplement#: 001
Type: SE1 to Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TAZORAC
Dosage Form: CREAM
Applicant: ALLERGAN INC
Active Ingredient(s): TAZAROTENE
OTC/RX Status: RX
Efficacy Claim: For acne vulgaris

Application #:019452Efficacy Supplement#:017
Type: SE5 to Original New Drug Application
Approval Date: 10-OCT-01
Trade Name: DERMA-SMOOTHE/FS
Dosage Form: OIL
Applicant: HILL DERMACEUTICALS INC
Active Ingredient(s): FLUOCINOLONE ACETONIDE
OTC/RX Status: RX
Efficacy Claim: For use in pediatric patients 2 years and older for the treatment of atopic dermatitis

Application #: 019555 Efficacy Supplement#: 016
Type: SE5 to Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROLENE AF
Dosage Form: CREAM, AUGMENTED
Applicant: SCHERING CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger

Application #: 018827 Efficacy Supplement#: 022
Type: SE5 to Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: LOTRISONE
Dosage Form: EMULSION, CREAM
Applicant: SCHERING CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
OTC/RX Status: RX
Efficacy Claim: For patients 17 years and older for the topical tretment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum

Application #: 017781 Efficacy Supplement#: 022
Type: SE5 to Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: LOTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger

Application #: 017691 Efficacy Supplement#: 024
Type: SE5 to Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: OINTMENT
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger

Application #: 017536 Efficacy Supplement#: 024
Type: SE5 to Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: CREAM
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX
Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger

Approvable Original New Drug Applications

Original Application #: 021219
Approvable Date: 02-OCT-01
Trade Name: XALCOM
Dosage Form: SOLUTION
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LATANOPROST; TIMOLOL MALEATE
OTC/RX Status: RX

Original Abbreviated New Drug Applications

Original Abbreviated Application # 076112
Approval Date: 31-OCT-01
Trade Name: IBUPROFEN
Dosage Form: TABLET
Applicant: DOCTOR REDDYS LABORATORIES LTD
Active Ingredient(s): IBUPROFEN
OTC/RX Status: RX

Original Abbreviated Application # 075697
Approval Date: 23-OCT-01
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 075695
Approval Date: 23-OCT-01
Trade Name: BUTORPHANOL TARTRATE
Dosage Form: INJECTABLE
Applicant: APOTEX CORP
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX

Original Abbreviated Application # 040423
Approval Date: 22-OCT-01
Trade Name: PREDNISOLONE
Dosage Form: SYRUP
Applicant: KV PHARMACEUTICAL CO
Active Ingredient(s): PREDNISOLONE
OTC/RX Status: RX

Original Abbreviated Application # 075909
Approval Date: 15-OCT-01
Trade Name: ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): HYDROCHLOROTHIAZIDE; ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 075515
Approval Date: 15-OCT-01
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: MUTUAL PHARMACEUTICAL CO INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075843
Approval Date: 3-OCT-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: PUREPACK PHARMACEUTICAL CO.
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX

Original Abbreviated Application # 075839
Approval Date: 1-OCT-01
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): MINOXIDIL
OTC/RX Status: RX

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

Original Abbreviated Application #: 075834
Tentative Approval Date: 30-OCT-01
Trade Name: MILRINONE LACTATE IN 5% DEXTROSE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORPORATION
Active Ingredient(s):MILRINONE LACTATE IN 5% DEXTROSE
OTC/RX Status: RX

Original Abbreviated Application #: 075674
Tentative Approval Date: 12-OCT-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application #: 075944
Tentative Approval Date: 09-OCT-01
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 021062 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 21062 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021062 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: INJECTABLE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021061 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021061 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 021061 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: TEQUIN
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): GATIFLOXACIN
OTC/RX Status: RX

Application #: 020903 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX

Application #: 020254 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: VOLTAREN-XR
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Application #: 020142 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: CATAFLAM
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DICLOFENAC POTASSIUM
OTC/RX Status: RX

Application #: 019201 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: VOLTAREN
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX

Application #: 019281 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: CYKLOKAPRON
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRANEXAMIC ACID
OTC/RX Status: RX

Application #: 018332 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: INDOCIN
Dosage Form: SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Application #: 018185 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: INDOCIN SR
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Application #: 017814 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: INDOCIN
Dosage Form: SUPPOSITORY
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Application #: 016059 Labeling Supplement#: 088
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: INDOCIN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDOMETHACIN
OTC/RX Status: RX

Application #: 014713 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: ETRAFON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
OTC/RX Status: RX

Application #: 011483 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 31-OCT-01
Trade Name: SYNALGOS-DC
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): DIHYDROCODEINE BITARTRATE; ASPIRIN; CAFFEINE
OTC/RX Status: RX

Application #: 021040 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 30-OCT-01
Trade Name: ORTHO-PREFEST
Dosage Form: TABLET
Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): ESTRADIOL; NORGESTIMATE
OTC/RX Status: RX

Application #: 019810 Labeling Supplement#: 073
To Original New Drug Application
Approval Date: 30-OCT-01
Trade Name: PRILOSEC
Dosage Form: CAPSULE
Applicant: ASTRAZENECA LP
Active Ingredient(s): OMEPRAZOLE
OTC/RX Status: RX

Application #: 018766 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 30-OCT-01
Trade Name: ANSAID
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): FLURBIPROFEN
OTC/RX Status: RX

Application #: 018766 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 30-OCT-01
Trade Name: ANSAID
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): FLURBIPROFEN
OTC/RX Status: RX

Application #:018662Labeling Supplement#:044
To Original New Drug Application
Approval Date: 30-OCT-01
Trade Name: ACCUTANE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): ISOTRETINOIN
OTC/RX Status: RX

Application #: 020898 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 26-OCT-01
Trade Name: THYROGEN
Dosage Form:INJECTABLE
Applicant: GENZYME CORP
Active Ingredient(s): THYROTROPIN ALFA
OTC/RX Status: RX

Application #: 020830 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 26-OCT-01
Trade Name: SINGULAIR
Dosage Form: TABLET, CHEWABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020829 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 26-OCT-01
Trade Name: SINGULAIR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): MONTELUKAST SODIUM
OTC/RX Status: RX

Application #: 020329 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 26-OCT-01
Trade Name: GLUCOTROL XL
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: PFIZER INC
Active Ingredient(s): GLIPIZIDE
OTC/RX Status: RX

Application #: 020903 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 24-OCT-01
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX

Application #: 020013 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 24-OCT-01
Trade Name: MAXAQUIN
Dosage Form: TABLET
Applicant: GD SEARLE AND CO
Active Ingredient(s): LOMEFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018257 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 24-OCT-01
Trade Name: TONOCARD
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): TOCAINIDE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 053
To Original New Drug Application
Approval Date: 23-OCT-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 019643 Labeling Supplement#: 069
To Original New Drug Application
Approval Date: 22-OCT-01
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX

Application #: 014547 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 18-OCT-01
Trade Name: MEPROBAMATE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): MEPROBAMATE
OTC/RX Status: RX

Application #: 011213 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 18-OCT-01
Trade Name: TRILAFON
Dosage Form: INJECTABLE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX

Application #: 010775 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 18-OCT-01
Trade Name: TRILAFON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX

Application #: 020972 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 16-OCT-01
Trade Name: SUSTIVA
Dosage Form: CAPSULE
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): EFAVIRENZ
OTC/RX Status: RX

Application #: 020413 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 16-OCT-01
Trade Name: ZERIT
Dosage Form: POWDER, FOR SOLUTION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 020412 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 16-OCT-01
Trade Name: ZERIT
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): STAVUDINE
OTC/RX Status: RX

Application #: 050643 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050558 Labeling Supplement#: 050
To Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: ZINACEF
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Application #: 050522 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: CECLOR
Dosage Form: SUSPENSION
Applicant: ELI LILLY AND CO
Active Ingredient(s): CEFACLOR
OTC/RX Status: RX

Application #: 021225 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 12-OCT-01
Trade Name: MIRENA
Dosage Form: INTRAUTERINE DEVICE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form:INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form:INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form:INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form:INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form:INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019645 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: TORADOL
Dosage Form: INJECTABLE
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX

Application #: 019583 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 11-OCT-01
Trade Name: RELAFEN
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): NABUMETONE
OTC/RX Status: RX

Application #: 016320 Labeling Supplement#: 056
To Original New Drug Application
Approval Date: 10-OCT-01
Trade Name: MYAMBUTOL
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): ETHAMBUTOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020518 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 05-OCT-01
Trade Name: RETROVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 019910 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 05-OCT-01
Trade Name: RETROVIR
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 019655 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 05-OCT-01
Trade Name: RETROVIR
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 020232 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 04-OCT-01
Trade Name: FIORICET W/ CODEINE
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
OTC/RX Status: RX

Application #: 019429 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 04-OCT-01
Trade Name: FIORINAL W/CODEINE
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): ASPIRIN; CAFFEINE; BUTALBITAL; CODEINE PHOSPHATE
OTC/RX Status: RX

Application #: 015034 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 04-OCT-01
Trade Name: PONSTEL
Dosage Form: CAPSULE
Applicant: PARKE-DAVIS
Active Ingredient(s): MEFENAMIC ACID
OTC/RX Status: RX

Application #: 021265 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: INFUVITE PEDIATRIC
Dosage Form: INJECTABLE
Applicant: SABEX INC
Active Ingredient(s): ASCORBIC ACID; VITAMIN A; CHOLECALCIFEROL; THIAMINE; RIBOFLAVIN; PYRIDOXINE; NIACINAMIDE; DEXPANTHENOL; TOCOPHEROL ACETATE; VITAMIN K; FOLIC ACID; BIOTIN; CYANOCOBALAMIN
OTC/RX Status: RX

Application #: 019555 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROLENE AF
Dosage Form: CREAM
Applicant: SCHERING CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 018827 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: LOTRISONE
Dosage Form: CREAM
Applicant: SCHERING CORP
Active Ingredient(s): CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 018827 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: LOTRISONE
Dosage Form: CREAM
Applicant: SCHERING CORP
Active Ingredient(s): CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 018827 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: LOTRISONE
Dosage Form: CREAM
Applicant: SCHERING CORP
Active Ingredient(s): CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 017781 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: LOTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 017691 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: OINTMENT
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 017536 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 03-OCT-01
Trade Name: DIPROSONE
Dosage Form: CREAM
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Application #: 019863 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 02-OCT-01
Trade Name: GEREF
Dosage Form: INJECTABLE
Applicant: SERONO LABORATORIES INC
Active Ingredient(s): SERMORELIN ACETATE
OTC/RX Status: RX

Application #: 050665 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: CEFZIL
Dosage Form: POWDER, FOR SUSPENSION
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #: 050664 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: CEFZIL
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): CEFPROZIL
OTC/RX Status: RX

Application #: 021151 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: BETAPACE AF
Dosage Form: TABLET
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019919 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: ROWASA
Dosage Form: SUPPOSITORY
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 019618 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: ROWASA
Dosage Form: ENEMA
Applicant: SOLVAY PHARMACEUTICALS
Active Ingredient(s): MESALAMINE
OTC/RX Status: RX

Application #: 018264 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: DANTRIUM
Dosage Form: INJECTABLE
Applicant: PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAM BLE CO
Active Ingredient(s): DANTROLENE SODIUM
OTC/RX Status: RX

Application #: 006188 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: PROPYLTHIOURACIL
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): PROPYLTHIOURACIL
OTC/RX Status: RX

Application #: 006188 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 01-OCT-01
Trade Name: PROPYLTHIOURACIL
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): PROPYLTHIOURACIL
OTC/RX Status: RX