Drug Approvals for April 2001
Definitions and Notes
Original New Drug Applications
Original Application #: 020949
Approval Date: 30-APR-01
Trade Name: ACCUNEB
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Indication(s): For the treatment of asthma-related bronchospasm in patients 2 to 12 years of age
Original Application #: 020983
Approval Date: 19-APR-01
Trade Name: VENTOLIN-HFA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INHALATION
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): ALBUTEROL SULFATE
OTC/RX Status: RX
Indication(s): For the treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older
Original Application #: 021259
Approval Date: 03-APR-01
Trade Name: METADATE CD
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: CELLTECH PHARMACEUTICALS INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of attention deficit disorder
Original Application #: 021160
Approval Date: 02-APR-01
Trade Name: PHOSLO
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: BRAINTREE LABORATORIES INC
Active Ingredient(s): CALCIUM ACETATE
OTC/RX Status: RX
Indication(s): For the control of hyperphosphatemia in end stage renal failure and does not promote aluminum absorption
Efficacy Supplemental New Drug Applications
Application #: 020896 Efficacy Supplement#: 006
Type: SE1 to Original New Drug Application
Approval Date: 30-APR-01
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HLR TECHNOLOGY
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX
Efficacy Claim: For the use as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred
Application #: 020547 Efficacy Supplement#: 014
Type: SE1 to Original New Drug Application
Approval Date: 27-APR-01
Trade Name: ACCOLATE
Dosage Form: TABLET
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): ZAFIRLUKAST
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis and chronic treatment of asthma in pediatric patients 5-6 years of age
Application#: 019979 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 18-APR-01
Trade Name: TICLID
Dosage Form: TABLET
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): TICLOPIDINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the use as an adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation
Application #: 020031 Efficacy Supplement#: 026
Type: SE1 to Original New Drug Application
Approval Date: 13-APR-01
Trade Name: PAXIL
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the treatment of generalized anxity disorder as a new indication
Application #: 020375 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 05-APR-01
Trade Name: CLIMARA
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Efficacy Claim: For the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause
Approvable Original New Drug Applications
Original Abbreviated Application # 075796
Approval Date: 30-APR-01
Trade Name: LEVONORGESTREL AND ETHINYL ESTRADIOL
Dosage Form: TABLET
Applicant: DURAMED PHARMACEUTICALS INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX
Original Abbreviated Application # 075290
Approval Date: 30-APR-01
Trade Name: PAMIDRONATE DISODIUM
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): PAMIDRONATE DISODIUM
OTC/RX Status: RX
Original Abbreviated Application # 075850
Approval Date: 27-APR-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX
Original Abbreviated Application # 075764
Approval Date: 27-APR-01
Trade Name: MESNA
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): MESNA
OTC/RX Status: RX
Original Abbreviated Application # 075500
Approval Date: 27-APR-01
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: UPSHER SMITH LABORATORIES INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075423
Approval Date: 27-APR-01
Trade Name: CLONAZEPAM
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Original Abbreviated Application # 075058
Approval Date: 27-APR-01
Trade Name: FLURBIPROFEN
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): FLURBIPROFEN
OTC/RX Status: RX
Original Abbreviated Application # 075906
Approval Date: 25-APR-01
Trade Name: PROGESTERONE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Original Abbreviated Application # 075730
Approval Date: 20-APR-01
Trade Name: THIOTEPA
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): THIOTEPA
OTC/RX Status: RX
Original Abbreviated Application # 075390
Approval Date: 19-APR-01
Trade Name: NAPROXEN
Dosage Form: TABLET
Applicant: ALPHAPHARM PTY LTD
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX
Original Abbreviated Application # 075457
Approval Date: 18-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075894
Approval Date: 18-APR-01
Trade Name: FLUVOXAMINE MALEATE
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX
Original Abbreviated Application # 075825
Approval Date: 17-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: BEN VENUE LABORATORIES INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 074567
Approval Date: 17-APR-01
Trade Name: IBUPROHM COLD & SINUS
Dosage Form: TABLET
Applicant: OHM LABORATORIES INC
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC
Original Abbreviated Application # 075708
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075707
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075488
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075669
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075709
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075486
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: ESI LEDERLE INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075311
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075805
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: CARLSBAD TECHNOLOGY INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075705
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075813
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075786
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: WOCKHARDT AMERICAS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075302
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075511
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075684
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075793
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075062
Approval Date: 16-APR-01
Trade Name: FAMOTDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075622
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075718
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075651
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075704
Approval Date: 16-APR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application # 075498
Approval Date: 12-APR-01
Trade Name: TERAZOSIN HCL
Dosage Form: CAPSULE
Applicant: TORPHARM INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075842
Approval Date: 12-APR-01
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX
Original Abbreviated Application # 075630
Approval Date: 12-APR-01
Trade Name: BETAXOLOL
Dosage Form: SOLUTION
Applicant: BAUSCH & LOMB PHARMACEUTICALS, INC
Active Ingredient(s): BETAXOLOL
OTC/RX Status: RX
Original Abbreviated Application # 075390
Approval Date: 10-APR-01
Trade Name: NAPROXEN
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALPHAPHARM PTY LTD
Active Ingredient(s): NAPROXEN
OTC/RX Status: RX
Original Abbreviated Application # 075547
Approval Date: 02-APR-01
Trade Name: THIOTEPA
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): THIOTEPA
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075049
Tentative Approval Date: 30-APR-01
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: GENEVA PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075869
Approval Date: 18-APR-01
Trade Name: LISINOPRIL and HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s):LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020896 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 30-APR-01
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HLR TECHNOLOGY
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX
Application #: 019880 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 30-APR-01
Trade Name: PARAPLATIN
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): CARBOPLATIN
OTC/RX Status: RX
Application #: 019880 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 30-APR-01
Trade Name: PARAPLATIN
Dosage Form: INJECTABLE
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Active Ingredient(s): CARBOPLATIN
OTC/RX Status: RX
Application #: 021228 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 27-APR-01
Trade Name: DETROL LA
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLTERODINE TARTRATE
OTC/RX Status: RX
Application #: 021085 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 27-APR-01
Trade Name: AVELOX
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): MOXIFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 021036 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 27-APR-01
Trade Name: RELENZA
Dosage Form: POWDER, FOR INHALATION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZANAMIVIR
OTC/RX Status: RX
Application #: 020428 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 27-APR-01
Trade Name: AZELEX
Dosage Form: EMULSION, CREAM
Applicant: ALLERGAN INC
Active Ingredient(s): AZELAIC ACID
OTC/RX Status: RX
Application #: 019700 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 27-APR-01
Trade Name: ACULAR
Dosage Form: SOLUTION
Applicant: ALLERGAN INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Application #: 021121 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 26-APR-01
Trade Name: CONCERTA
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #:019643Labeling Supplement#:064
To Original New Drug Application
Approval Date: 26-APR-01
Trade Name:MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Application #: 019643 Labeling Supplement#: 062
To Original New Drug Application
Approval Date: 26-APR-01
Trade Name: MEVACOR
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): LOVASTATIN
OTC/RX Status: RX
Application #: 020752 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 25-APR-01
Trade Name: PEPCID RPD
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Application #: 020249 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 25-APR-01
Trade Name: PEPCID PRESERVATIVE FREE
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Application #: 019527 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 25-APR-01
Trade Name: PEPCID
Dosage Form: POWDER, FOR SUSPENSION
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Application #: 019510 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 25-APR-01
Trade Name: PEPCID
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Application #: 019462 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 25-APR-01
Trade Name: PEPCID
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Application #: 020676 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 24-APR-01
Trade Name: VAGISTAT-1
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): TIOCONAZOLE
OTC/RX Status: OTC
Application #: 020676 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 24-APR-01
Trade Name: VAGISTAT-1
Dosage Form: OINTMENT
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): TIOCONAZOLE
OTC/RX Status: OTC
Application #: 020471 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 23-APR-01
Trade Name: ZYFLO
Dosage Form: TABLET
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): ZILEUTON
OTC/RX Status: RX
Application #: 020491 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 20-APR-01
Trade Name: CORVERT
Dosage Form: INJECTABLE
Applicant: PHARMACIA & UPJOHN
Active Ingredient(s): IBUTILIDE FUMARATE
OTC/RX Status: RX
Application #: 017441 Labeling Supplement#: 161
To Original New Drug Application
Approval Date: 18-APR-01
Trade Name: INFED
Dosage Form: INJECTABLE
Applicant: SCHEIN PHARMACEUTICAL INC
Active Ingredient(s): IRON DEXTRAN
OTC/RX Status: RX
Application #: 019885 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 17-APR-01
Trade Name: ACCUPRIL
Dosage Form: TABLET
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): QUINAPRIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020648 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 11-APR-01
Trade Name: DIASTAT
Dosage Form: GEL
Applicant: ELAN PHARMACEUTICALS INC
Active Ingredient(s): DIAZEPAM
OTC/RX Status: RX
Application #: 020312 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 11-APR-01
Trade Name: UNIVASC
Dosage Form: TABLET
Applicant: SCHWARZ PHARMA INC
Active Ingredient(s): MOEXIPRIL HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017555 Labeling Supplement#: 055
To Original New Drug Application
Approval Date: 11-APR-01
Trade Name: SINEMET
Dosage Form: TABLET
Applicant: DUPONT PHARMACEUTICALS CO
Active Ingredient(s): CARBIDOPA; LEVODOPA
OTC/RX Status: RX
Application #: 017533 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 11-APR-01
Trade Name: KLONOPIN
Dosage Form: TABLET
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): CLONAZEPAM
OTC/RX Status: RX
Application #: 020201 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 10-APR-01
Trade Name: DOBUTAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018826 Labeling Supplement#: 027
To Original New Drug Application
Approval Date: 10-APR-01
Trade Name: DOPAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
Active Ingredient(s): DOPAMINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #: 016267 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: DESFERAL
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): DEFEROXAMINE MESYLATE
OTC/RX Status: RX
Application #: 012380 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: ZARONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): ETHOSUXIMIDE
OTC/RX Status: RX
Application #: 012380 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: ZARONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): ETHOSUXIMIDE
OTC/RX Status: RX
Application #: 012380 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: ZARONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): ETHOSUXIMIDE
OTC/RX Status: RX
Application #: 010596 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: CELONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): METHSUXIMIDE
OTC/RX Status: RX
Application #: 010596 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-APR-01
Trade Name: CELONTIN
Dosage Form: CAPSULE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): METHSUXIMIDE
OTC/RX Status: RX
Application #: 020392 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 06-APR-01
Trade Name: CYSTAGON
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): CYSTEAMINE BITARTRATE
OTC/RX Status: RX
Application #: 019650 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 06-APR-01
Trade Name: FLUMADINE
Dosage Form: SYRUP
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): RIMANTADINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019649 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 06-APR-01
Trade Name: FLUMADINE
Dosage Form: TABLET
Applicant: FOREST LABORATORIES INC
Active Ingredient(s): RIMANTADINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020779 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 05-APR-01
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020778 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 05-APR-01
Trade Name: VIRACEPT
Dosage Form: POWDER
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX
Application #: 019860 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 05-APR-01
Trade Name: IMODIUM A-D
Dosage Form: TABLET
Applicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
OTC/RX Status: OTC
Application #: 020375 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 04-APR-01
Trade Name: CLIMARA
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): ESTRADIOL
OTC/RX Status: RX
Application #: 016295 Labeling Supplement#: 034
To Original New Drug Application
Approval Date: 04-APR-01
Trade Name: HYDREA
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): HYDROXYUREA
OTC/RX Status: RX
Application #: 021019 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX
Application #: 020756 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: CRINONE
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Application #: 020701 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: CRINONE
Dosage Form: GEL
Applicant: COLUMBIA RESEARCH LABORATORIES INC
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX
Application #: 011552 Labeling Supplement#: 112
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: STELAZINE
Dosage Form: TABLET, FILM COATED
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS CO
Active Ingredient(s): TRIFLUOPERAZINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 011188 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: SYRUP
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PROCHLORPERAZINE EDISYLATE
OTC/RX Status: RX
Application #: 011127 Labeling Supplement#: 061
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: SUPPOSITORY
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PROCHLORPERAZINE
OTC/RX Status: RX
Application #: 011120 Labeling Supplement#: 086
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: THORAZINE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): CHLORPROMAZINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 011000 Labeling Supplement#: 084
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX
Application #: 010742 Labeling Supplement#: 065
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: INJECTABLE
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PROCHLORPERAZINE EDISYLATE
OTC/RX Status: RX
Application #: 010571 Labeling Supplement#: 095
To Original New Drug Application
Approval Date: 03-APR-01
Trade Name: COMPAZINE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): PROCHLORPERAZINE MALEATE
OTC/RX Status: RX
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Date created: July 17, 2001; last updated: June 20, 2005 |