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 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