Drug Approvals for March 2001

Definitions and Notes

Original New Drug Applications

Original Application #: 021304
Approval Date: 29-MAR-01
Trade Name: VALCYTE
Chemical Type: 2
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: SYNTEX (USA) INC LLC
Active Ingredient(s): VALGANCICLOVIR HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): For the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS)

Original Application #: 020988
Approval Date: 22-MAR-01
Trade Name: PROTONIX
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX
Indication(s): For short term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD), as an alternative to oral therapy in patients who are unable to take Protonix

Original Application #: 020950
Approval Date: 21-MAR-01
Trade Name: DUONEB
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: SOLUTION, FOR INHALATION
Applicant: DEY LABORATORIES INC
Active Ingredient(s): ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
OTC/RX Status: RX
Indication(s): For the treatment of bronchospasm associated with COPD for patients who require more than one bronchodilator

Original Application #: 021124
Approval Date: 17-MAR-00
Trade Name: LAMISIL
Chemical Type: 6
Therapeutic Potential: S
Dosage Form: SOLUTION
Applicant: NOVARTIS PHARMACEUTICALS CORPORATION
Active Ingredient(s): TERBINAFINE HYDROCHLORIDE
OTC/RX Status: RX
Indication(s): Provides for use without prescription of Lamisil AT Spray Pump (terbinafine hydrochloride solution, 1%) and Lamisil AT Solution Dropper (terbinafine hydrochloride solution, 1%) for the treatment of interdigital-type tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm) due to Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccosum.

Original Application #: 021082
Approval Date: 01-MAR-01
Trade Name: TAVIST ALLERGY/SINUS/HEADACHE
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: NOVARTIS CONSUMER HEALTH INC
Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC
Indication(s): For temporary relief of symptoms associated with hay fever, allergic rhinitis, and the common cold

Efficacy Supplemental New Drug Applications

Application #: 020463 Efficacy Supplement#: 002
Type: SE5 to Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: NASALCROM
Dosage Form: SPRAY, METERED
Applicant: PHARMACIA AND UPJOHN CONSUMER HEALTHCARE
Active Ingredient(s): CROMOLYN SODIUM
OTC/RX Status: OTC
Efficacy Claim: For use in children down to 2 years of age

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075726
Approval Date: 30-MAR-01
Trade Name: PEMOLINE
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): PEMOLINE
OTC/RX Status: RX

Original Abbreviated Application # 075424
Approval Date: 30-MAR-01
Trade Name: AMIODARONE HCL
Dosage Form: TABLET
Applicant: TARO PHARMACEUTICALS USA INC
Active Ingredient(s): AMIODARONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075881
Approval Date: 29-MAR-01
Trade Name: LEVOCARNITINE
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Original Abbreviated Application # 040404
Approval Date: 29-MAR-01
Trade Name: METHYLPHENIDATE HCL
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075567
Approval Date: 29-MAR-01
Trade Name: LEVOCARNITINE
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): LEVOCARNITINE
OTC/RX Status: RX

Original Abbreviated Application # 075627
Approval Date: 28-MAR-01
Trade Name: ACYCLOVIR SODIUM
Dosage Form: INJECTABLE
Applicant: GENSIA SICOR PHARMACEUTICALS INC
Active Ingredient(s): ACYCLOVIR SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075467
Approval Date: 28-MAR-01
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075441
Approval Date: 28-MAR-01
Trade Name: IPRATROPIUM BROMIDE
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): IPRATROPIUM BROMIDE
OTC/RX Status: RX

Original Abbreviated Application # 075272
Approval Date: 28-MAR-01
Trade Name: BUSPIRONE HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 074253
Approval Date: 28-MAR-01
Trade Name: BUSPIRONE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075297
Approval Date: 27-MAR-01
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: ZENITH GOLDLINE PHARMACEUTICALS
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX

Original Abbreviated Application # 040411
Approval Date: 27-MAR-01
Trade Name: METHIMAZOLE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): METHIMAZOLE
OTC/RX Status: RX

Original Abbreviated Application # 075618
Approval Date: 23-MAR-01
Trade Name: ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Dosage Form: CAPSULE, HARD GELATIN
Applicant: WEST WARD PHARMACEUTICAL CORP
Active Ingredient(s): ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Application # 075178
Approval Date: 23-MAR-01
Trade Name: ENALAPRIL MALEATE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): ENALAPRIL MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 040385
Approval Date: 21-MAR-01
Trade Name: METHOTREXATE SODIUM
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): METHOTREXATE SODIUM
OTC/RX Status: RX

Original Abbreviated Antibiotic Application #065028
Approval Date: 14-MAR-01
Trade Name: RIFAMPIN
Dosage Form: CAPSULE
Applicant: VERSAPHARM INC
Active Ingredient(s): RIFAMPIN
OTC/RX Status: RX

Original Abbreviated Application # 040388
Approval Date: 13-MAR-01
Trade Name: HYDRALAZINE HCL
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): HYDRALAZINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application # 075898
Approval Date: 12-MAR-01
Trade Name: FLUVOXAMINE MALEATE
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

Original Abbreviated Application # 075751
Approval Date: 12-MAR-01
Trade Name: DESONIDE
Dosage Form: OINTMENT
Applicant: ALTANA INC
Active Ingredient(s): DESONIDE
OTC/RX Status: RX

Original Abbreviated Application # 075128
Approval Date: 10-MAR-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORPORATION
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Original Abbreviated Application # 075689
Approval Date: 09-MAR-01
Trade Name: HALOPERIDOL LACTATE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): HALOPERIDOL LACTATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075747
Tentative Approval Date: 30-MAR-01
Trade Name: CIPROFLOXACIN
Dosage Form: TABLET
Applicant: RANBAXY PHARMACEUTICALS INC
Active Ingredient(s): CIPROFLOXACIN HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075786
Tentative Approval Date: 28-MAR-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: WOCKHARDT AMERICAS INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application #: 075659
Tentative Approval Date: 20-MAR-01
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: ELAN PHARMACEUTICAL RESEARCH CORP
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020740 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX

Application #: 020518 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: RETROVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 020315 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: ORLAAM
Dosage Form: CONCENTRATE
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LEVOMETHADYL ACETATE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019910 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: RETROVIR
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 019655 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: RETROVIR
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ZIDOVUDINE
OTC/RX Status: RX

Application #: 018554 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 23-MAR-01
Trade Name: EULEXIN
Dosage Form: CAPSULE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): FLUTAMIDE
OTC/RX Status: RX

Application #: 018519 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 30-MAR-01
Trade Name: IRRIGATING SOLUTION G IN PLASTIC CONTAINER
Dosage Form: SOLUTION
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): CITRIC ACID; SODIUM CARBONATE; MAGNESIUM OXIDE
OTC/RX Status: RX

Application #: 020549 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 29-MAR-01
Trade Name: FLOVENT
Dosage Form: POWDER FOR INHALATION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): FLUTICASONE PROPIONATE
OTC/RX Status: RX

Application #: 020363 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 29-MAR-01
Trade Name: FAMVIR
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): FAMCICLOVIR
OTC/RX Status: RX

Application #: 020779 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 28-MAR-00
Trade Name: VIRACEPT
Dosage Form: TABLET
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020778 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 28-MAR-00
Trade Name: VIRACEPT
Dosage Form: POWDER
Applicant: AGOURON PHARMACEUTICALS INC
Active Ingredient(s): NELFINAVIR MESYLATE
OTC/RX Status: RX

Application #: 020639 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: SEROQUEL
Dosage Form: TABLET
Applicant: ASTRAZENECA UK LTD
Active Ingredient(s): QUETIAPINE FUMARATE
OTC/RX Status: RX

Application #: 020409 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: NASAREL
Dosage Form: SPRAY, METERED
Applicant: DURA TRADING CO LTD
Active Ingredient(s): FLUNISOLIDE
OTC/RX Status: RX

Application #: 19281 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: CYKLOKAPRON
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRANEXAMIC ACID
OTC/RX Status: RX

Application #: 017362 Labeling Supplement #: 089
To Original New Drug Application
Approval Date: 27-MAR-00
Trade Name: PROGESTERONE INJECTION
Dosage Form: INJECTABLE
Applicant: SCHEIN PHARMACEUTICALS
Active Ingredient(s): PROGESTERONE
OTC/RX Status: RX

Application #: 012704 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: ELAVIL
Dosage Form: INJECTABLE
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012703 Labeling Supplement#: 092
To Original New Drug Application
Approval Date: 27-MAR-01
Trade Name: ELAVIL
Dosage Form: TABLET
Applicant: ASTRAZENECA PHARMACEUTICALS LP
Active Ingredient(s): AMITRIPTYLINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020896 Labeling Supplement #: 007
To Original New Drug Application
Approval Date: 24-MAR-00
Trade Name: XELODA
Dosage Form: TABLET
Applicant: HOFFMAN LA ROCHE INC
Active Ingredient(s): CAPECITABINE
OTC/RX Status: RX

Application #: 020401 Labeling Supplement #: 019
To Original New Drug Application
Approval Date: 24-MAR-00
Trade Name: TIAZAC
Dosage Form: CAPSULE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020913 Labeling Supplement#: 006
To Original New Drug Application
Approval Date: 23-MAR-01
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020912 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 23-MAR-01
Trade Name: AGGRASTAT
Dosage Form: INJECTABLE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): TIROFIBAN HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019192 Labeling Supplement #: 035
To Original New Drug Application
Approval Date: 23-MAR-00
Trade Name: TRIPHASIL-21
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL; LEVONORGESTR EL; ETHINYL ESTRADIOL; LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 019190 Labeling Supplement #: 036
To Original New Drug Application
Approval Date: 23-MAR-00
Trade Name: TRIPHASIL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL; ETHINYL ESTRADIOL; LEVONORGESTR EL; ETHINYL ESTRADIOL; LEVONORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016806 Labeling Supplement#: 028
To Original New Drug Application
Approval Date: 23-MAR-01
Trade Name: OVRAL-28
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 016672 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 23-MAR-01
Trade Name: OVRAL
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL
OTC/RX Status: RX

Application #: 020685 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: CRIXIVAN
Dosage Form: CAPSULE
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): INDINAVIR SULFATE
OTC/RX Status: RX

Application #: 020152 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018571 Labeling Supplement #: 015
To Original New Drug Application
Approval Date: 21-MAR-00
Trade Name: BRETHINE
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): TERBUTALINE SULFATE
OTC/RX Status: RX

Application #: 011795 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: VISTARIL
Dosage Form: SUSPENSION
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE PAMOATE
OTC/RX Status: RX

Application #: 011459 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: VISTARIL
Dosage Form: CAPSULE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE PAMOATE
OTC/RX Status: RX

Application #: 011111 Labeling Supplement#: 033
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: VISTARIL
Dosage Form: INJECTABLE
Applicant: PFIZER LABORATORIES DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 010485 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: ATARAX
Dosage Form: SYRUP
Applicant: ROERIG DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 010392 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 21-MAR-01
Trade Name: ATARAX
Dosage Form: TABLET
Applicant: ROERIG DIV PFIZER INC
Active Ingredient(s): HYDROXYZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019758 Labeling Supplement #: 041
To Original New Drug Application
Approval Date: 17-MAR-00
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX

Application #: 017923 Labeling Supplement#: 049
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: MELLARIL-S
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIORIDAZINE
OTC/RX Status: RX

Application #: 016997 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: SERENTIL
Dosage Form: CONCENTRATE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 016775 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: SERENTIL
Dosage Form: INJECTABLE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 016774 Labeling Supplement#: 073
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: SERENTIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): MESORIDAZINE BESYLATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 048
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 046
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 040
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET, FILM COATED
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 012342 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: PARNATE
Dosage Form: TABLET
Applicant: SMITHKLINE BEECHAM PHARMACEUTICALS
Active Ingredient(s): TRANYLCYPROMINE SULFATE
OTC/RX Status: RX

Application #: 011808 Labeling Supplement#: 178
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: MELLARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): THIORIDAZINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 011213 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: TRILAFON
Dosage Form: INJECTIABLE
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX

Application #: 010775 Labeling Supplement#: 029
To Original New Drug Application
Approval Date: 15-MAR-01
Trade Name: TRILAFON
Dosage Form: TABLET
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): PERPHENAZINE
OTC/RX Status: RX

Application #: 019527 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 14-MAR-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 #: 020752 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 14-MAR-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 #: 012
To Original New Drug Application
Approval Date: 14-MAR-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 #: 019510 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 14-MAR-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 #: 031
To Original New Drug Application
Approval Date: 14-MAR-01
Trade Name: PEPCID
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Application #: 020675 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 08-MAR-01
Trade Name: URSO
Dosage Form: TABLET
Applicant: AXCAN SCANDIPHARM INC
Active Ingredient(s): URSODIOL
OTC/RX Status: RX

Application #: 018261 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 08-MAR-01
Trade Name: PITOCIN
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS INC
Active Ingredient(s): OXYTOCIN
OTC/RX Status: RX

Application #: 020234 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 07-MAR-01
Trade Name: TEGRETOL-XR
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018927 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 07-MAR-01
Trade Name: TEGRETOL
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 018281 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 07-MAR-01
Trade Name: TEGRETOL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 016608 Labeling Supplement#: 090
To Original New Drug Application
Approval Date: 07-MAR-01
Trade Name: TEGRETOL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CARBAMAZEPINE
OTC/RX Status: RX

Application #: 020945 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 06-MAR-01
Trade Name: NORVIR
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020659 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 06-MAR-01
Trade Name: NORVIR
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV
Active Ingredient(s): RITONAVIR
OTC/RX Status: RX

Application #: 020596 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 06-MAR-01
Trade Name: EPIVIR
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020564 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 06-MAR-01
Trade Name: EPIVIR
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): LAMIVUDINE
OTC/RX Status: RX

Application #: 020204 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 06-MAR-01
Trade Name: ALEVE
Dosage Form: TABLET
Applicant: BAYER CORP CONSUMER CARE DIV
Active Ingredient(s): NAPROXEN
OTC/RX Status: OTC

Application #: 019508 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 02-MAR-01
Trade Name: AXID
Dosage Form: CAPSULE
Applicant: ELI LILLY AND CO
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX