Drug Approvals for May 2001

Definitions and Notes

Original New Drug Applications

Original Abbreviated Application # 075312
Approval Date: 31-MAY-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application # 040419
Approval Date: 31-MAY-01
Trade Name: ACETAMINOPHEN AND CODEINE PHOSPHATE
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): ACETAMINOPHEN; CODEINE PHOSPHATE
OTC/RX Status: RX

Original Abbreviated Antibiotic Application #065001
Approval Date: 30-MAY-01
Trade Name: CEFUROXIME
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): CEFUROXIME SODIUM
OTC/RX Status: RX

Original Abbreviated Application # 075673
Approval Date: 29-MAY-01
Trade Name: BETAMETHASONE DIPROPIONATE AND CLOTRIMAZOLE
Dosage Form: CREAM
Applicant: TARO PHARMACEUTICALS USA INC
Active Ingredient(s): CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
OTC/RX Status: RX

Original Application #: 021301
Approval Date: 25-MAY-01
Trade Name: LEVOXYL
Chemical Type: 5
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: JONES PHARMA INC
Active Ingredient(s): LEVOTHYROXINE SODIUM
OTC/RX Status: RX
Indication(s): For Hypothyroidism and suppression of thyroid-stimulating hormone

Original Application #: 021285
Approval Date: 25-MAY-01
Trade Name: TRILEPTAL
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: SUSPENSION
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): OXCARBAZEPINE
OTC/RX Status: RX
Indication(s): For the use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults with epilepsy and as adjunctive therapy in the treatment of partial seizures in children ages 4-16 with epilepsy

Original Application #: 021335
Approval Date: 10-MAY-01
Trade Name: GLEEVEC
Chemical Type: 1
Therapeutic Potential: P
Dosage Form: CAPSULE
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): IMATINIB MESYLATE
OTC/RX Status: RX
Indication(s): For the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of inteferon-alpha therapy

Original Application #: 021001
Approval Date: 07-MAY-01
Trade Name: AXERT
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALMOTRIPTAN MALATE
OTC/RX Status: RX
Indication(s): For the treatment of acute migraine

Original Application #: 021281
Approval Date: 03-MAY-01
Trade Name: PREVACID
Chemical Type:
Therapeutic Potential:
Dosage Form: SUSPENSION, DELAYED RELEASE
Applicant: TAP PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): LANSOPRAZOLE
OTC/RX Status: RX
Indication(s): For the short-term treatment of active duodenal ulcer, H. Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including Zollinger-Ellison syndrome

Efficacy Supplemental New Drug Applications

Application #: 020757 Efficacy Supplement#: 014
Type: SE5 to Original New Drug Application
Approval Date: 26-MAY-01
Trade Name: AVAPRO
Dosage Form: TABLET
Applicant:BRISTOL-MYERS SQUIBB
Active Ingredient(s): IRBESARTAN
OTC/RX Status: RX
Efficacy Claim: For the treatment of hypertension

Application #: 021039 Efficacy Supplement#: 006
Type: SE7 to Original New Drug Application
Approval Date: 11-MAY-01
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX
Efficacy Claim: For the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection

Application #: 021007 Efficacy Supplement#: 006
Type: SE7 to Original New Drug Application
Approval Date: 11-MAY-01
Trade Name: AGENERASE
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX
Efficacy Claim: For the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection

Application #: 020586 Efficacy Supplement#: 004
Type: SE2 to Original New Drug Application
Approval Date: 10-MAY-01
Trade Name: PRANACTIN-CITRIC
Dosage Form: POWDER, FOR SOLUTION
Applicant: MERETEK DIAGNOSTICS INC
Active Ingredient(s): UREA, C-13
OTC/RX Status: RX
Efficacy Claim: For use in the qualitative detection of urease associated with Helicobacter pylori in the human stomach and as an aid in the initial diagnosis and post-treatment monitoring of Helicobacter pylori infection in adult patients

Application #: 020657 Efficacy Supplement#: 005
Type: SE1 to Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Efficacy Claim: For empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN)

Application #: 020966 Efficacy Supplement#: 004
Type: SE1 to Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: INJECTABLE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX
Efficacy Claim: For empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN)

Application #: 020699 Efficacy Supplement#: 016
Type: SE1 to Original New Drug Application
Approval Date: 02-MAY-01
Trade Name: EFFEXOR XR
Dosage Form: CAPSULE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the prevention of recurrence of depression and for the prevention of relapse of depression

Application #: 020151 Efficacy Supplement#: 018
Type: SE1 to Original New Drug Application
Approval Date: 02-MAY-01
Trade Name: EFFEXOR
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): VENLAFAXINE HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim: For the prevention of recurrence of depression and for the prevention of relapse of depression

Approvable Original New Drug Applications

Original Abbreviated New Drug Applications

Original Abbreviated Application # 075951
Approval Date: 25-MAY-01
Trade Name: NORETHINDRONE ACETATE
Dosage Form: TABLET
Applicant: BARR LABORATORIES INC
Active Ingredient(s): NORETHINDRONE ACETATE
OTC/RX Status: RX

Original Abbreviated Application # 075602
Approval Date: 24-MAY-01
Trade Name: AMINOCAPROIC ACID
Dosage Form: TABLET
Applicant: MIKART INC
Active Ingredient(s): AMINOCAPROIC ACID
OTC/RX Status: RX

Original Abbreviated Application # 075607
Approval Date: 10-MAY-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: INVAMED INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075591
Approval Date: 10-MAY-01
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX

Original Abbreviated Application # 075902
Approval Date: 07-MAY-01
Trade Name: FLUVOXAMINE MALEATE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): FLUVOXAMINE MALEATE
OTC/RX Status: RX

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

Original Abbreviated Application #: 075872
Tentative Approval Date: 31-MAY-01
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075404
Tentative Approval Date: 31-MAY-01
Trade Name: FAMOTIDINE
Dosage Form: TABLET
Applicant: DANBURY PHARMACAL INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC

Original Abbreviated Application #: 075112
Tentative Approval Date: 31-MAY-01
Trade Name: DIVALPROEX SODIUM
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: TORPHARM INC
Active Ingredient(s): DIVALPROEX SODIUM
OTC/RX Status: RX

Original Abbreviated Application #: 075356
Tentative Approval Date: 24-MAY-01
Trade Name: PAROXETINE HCL
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): PAROXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075994
Tentative Approval Date: 24-MAY-01
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): LISINOPRIL
OTC/RX Status: RX

Original Abbreviated Application #: 075762
Tentative Approval Date: 23-MAY-01
Trade Name: OFLOXACIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): OFLOXACIN
OTC/RX Status: RX

Original Abbreviated Application #: 075401
Tentative Approval Date: 14-MAY-01
Trade Name: TAZTIA
Dosage Form: CAPSULE, EXTENDED-RELEASE
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): DILTIAZEM HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075690
Tentative Approval Date: 10-MAY-01
Trade Name: FLUOXETINE HCL
Dosage Form: SOLUTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX

Original Abbreviated Application #: 075521
Tentative Approval Date: 9-MAY-01
Trade Name: BUSPIRONE HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TORPHARM
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Labeling Supplements to Original New Drug Applications

Application #: 020255 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 31-MAY-01
Trade Name: DOBUTAMINE HCL IN DEXTROSE 5%
Dosage Form: INJECTABLE
Applicant: BAXTER HEALTHCARE CORP
Active Ingredient(s): DOBUTAMINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018604 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 30-MAY-01
Trade Name: ZOVIRAX
Dosage Form: OINTMENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 018604 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 30-MAY-01
Trade Name: ZOVIRAX
Dosage Form: OINTMENT
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ACYCLOVIR
OTC/RX Status: RX

Application #: 020520 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 29-MAY-01
Trade Name: ZANTAC 75
Dosage Form: TABLET
Applicant: WARNER LAMBERT CO CONSUMER PRODUCTS DIV
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 018206 Labeling Supplement#: 013
To Original New Drug Application
Approval Date: 24-MAY-01
Trade Name: LO/OVRAL-28 AND FERROUS FUMARATE
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): NORGESTREL; ETHINYL ESTRADIOL; FERROUS FUMARATE
OTC/RX Status: RX

Application #: 019771 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 23-MAY-01
Trade Name: ADVIL COLD AND SINUS
Dosage Form: TABLET
Applicant: WHITEHALL LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 017938 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 22-MAY-01
Trade Name: MOBAN
Dosage Form: CONCENTRATE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): MOLINDONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 017111 Labeling Supplement#: 055
To Original New Drug Application
Approval Date: 22-MAY-01
Trade Name: MOBAN
Dosage Form: CAPSULE
Applicant: ENDO PHARMACEUTICALS INC
Active Ingredient(s): MOLINDONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 012015 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 22-MAY-01
Trade Name: COGENTIN
Dosage Form: INJECTABLE
Applicant: MERCK AND CO INC
Active Ingredient(s): BENZTROPINE MESYLATE
OTC/RX Status: RX

Application #: 009193 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 22-MAY-01
Trade Name: COGENTIN
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): BENZTROPINE MESYLATE
OTC/RX Status: RX

Application #: 020987 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 21-MAY-01
Trade Name: PROTONIX
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PANTOPRAZOLE SODIUM
OTC/RX Status: RX

Application #: 020845 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 21-MAY-01
Trade Name: INOMAX
Dosage Form: GAS, FOR INHALATION
Applicant: INO THERAPEUTICS INC
Active Ingredient(s): NITRIC OXIDE
OTC/RX Status: RX

Application #: 020740 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 21-MAY-01
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX

Application #: 012223 Labeling Supplement#: 036
To Original New Drug Application
Approval Date: 18-MAY-01
Trade Name: AQUAMEPHYTON
Dosage Form: INJECTABLE
Applicant: MERCK & CO INC
Active Ingredient(s): PHYTONADIONE
OTC/RX Status: RX

Application #: 020315 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-MAY-01
Trade Name: ORLAAM
Dosage Form: SOLUTION
Applicant: ROXANE LABORATORIES INC
Active Ingredient(s): LEVOMETHADYL ACETATE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020236 Labeling Supplement#: 023
To Original New Drug Application
Approval Date: 17-MAY-01
Trade Name: SEREVENT
Dosage Form: AEROSOL, METERED
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 020692 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 17-MAY-01
Trade Name: SEREVENT
Dosage Form: POWDER, FOR INHALATION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SALMETEROL XINAFOATE
OTC/RX Status: RX

Application #: 021057 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 15-MAY-01
Trade Name: ANTAGON
Dosage Form: INJECTABLE
Applicant: ORGANON INC
Active Ingredient(s): GANIRELIX ACETATE
OTC/RX Status: RX

Application #: 018932 Labeling Supplement#: 015
To Original New Drug Application
Approval Date: 15-MAY-01
Trade Name: REVIA
Dosage Form: TABLET
Applicant: DUPONT MERCK PHARMACEUTICAL CO
Active Ingredient(s): NALTREXONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019814 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 14-MAY-01
Trade Name: BETAGAN
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019771 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 14-MAY-01
Trade Name: ADVIL COLD AND SINUS
Dosage Form: TABLET
Applicant: WHITEHALL LABORATORIES INC DIV AMERICAN HOME PRODUCTS CORP
Active Ingredient(s): IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
OTC/RX Status: OTC

Application #: 019219 Labeling Supplement#: 019
To Original New Drug Application
Approval Date: 14-MAY-01
Trade Name: BETAGAN
Dosage Form: SOLUTION
Applicant: ALLERGAN PHARMACEUTICAL
Active Ingredient(s): LEVOBUNOLOL HYDROCHLORIDE
OTC/RX Status: RX

Application #: 050668 Labeling Supplement#: 022
To Original New Drug Application
Approval Date: 11-MAY-01
Trade Name: LORABID
Dosage Form: CAPSULE
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX

Application #: 050667 Labeling Supplement#: 020
To Original New Drug Application
Approval Date: 11-MAY-01
Trade Name: LORABID
Dosage Form: POWDER, FOR SUSPENSION
Applicant: KING PHARMACEUTICALS INC
Active Ingredient(s): LORACARBEF
OTC/RX Status: RX

Application #: 021039 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 021007 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: AGENERASE
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX

Application #: 020966 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: INJECTABLE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020966 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: INJECTABLE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020657 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: SOLUTION
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 020251 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020095 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC 150
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 020083 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: SPORANOX
Dosage Form: CAPSULE
Applicant: JANSSEN RESEARCH FDN DIV JOHNSON AND JOHNSON
Active Ingredient(s): ITRACONAZOLE
OTC/RX Status: RX

Application #: 019675 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019593 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 019090 Labeling Supplement#: 044
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018703 Labeling Supplement#: 060
To Original New Drug Application
Approval Date: 09-MAY-01
Trade Name: ZANTAC
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 011719 Labeling Supplement#: 100
To Original New Drug Application
Approval Date: 08-MAY-01
Trade Name: METHOTREXATE SODIUM
Dosage Form: INJECTABLE
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): METHOTREXATE SODIUM
OTC/RX Status: RX

Application #: 008085 Labeling Supplement#: 051
To Original New Drug Application
Approval Date: 08-MAY-01
Trade Name: AMINOPTERIN SODIUM
Dosage Form: TABLET
Applicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Active Ingredient(s): AMINOPTERIN SODIUM
OTC/RX Status: RX

Application #: 050628 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 07-MAY-01
Trade Name: TOBRAFLEX
Dosage Form: SUSPENSION
Applicant: ALCON LABORATORIES INC
Active Ingredient(s): TOBRAMYCIN; FLUOROMETHOLONE ACETATE
OTC/RX Status: RX

Application #: 019059 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 03-MAY-01
Trade Name: INDERIDE LA 80/50
Dosage Form: CAPSULE, EXTENDED RELEASE
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 018731 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 03-MAY-01
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018731 Labeling Supplement#: 039
To Original New Drug Application
Approval Date: 03-MAY-01
Trade Name: BUSPAR
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUSPIRONE HYDROCHLORIDE
OTC/RX Status: RX

Application #: 018031 Labeling Supplement#: 031
To Original New Drug Application
Approval Date: 03-MAY-01
Trade Name: INDERIDE-40/25
Dosage Form: TABLET
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX

Application #: 020579 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 01-MAY-01
Trade Name: FLOMAX
Dosage Form: CAPSULE
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): TAMSULOSIN HYDROCHLORIDE
OTC/RX Status: RX