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Drug Approvals for November 2000
Definitions and Notes
Original New Drug Applications
Original Application #: 050782
Approval Date: 27-NOV-00
Trade Name: TRADENAME
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: TARGET RESEARCH ASSOCIATES
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Indication(s): FOR ONCE A DAY TREATMENT OF ACNE VULGARIS
Original Application #: 050769
Approval Date: 27-NOV-00
Trade Name: BENZAMYCIN
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: GEL
Applicant: DERMIK LABORATORIES, INC
Active Ingredient(s): ERYTHROMYCIN; BENZOYL PEROXIDE
OTC/RX Status: RX
Indication(s): FOR TREATMENT OF ACNE VULGARIS
Original Application #: 021162
Approval Date: 17-NOV-00
Trade Name: MICARDIS
Chemical Type: 4
Therapeutic Potential: S
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; TELMISARTAN
OTC/RX Status: RX
Indication(s):For the treatment of hypertension
Original Application #: 021205
Approval Date: 14-NOV-00
Trade Name: TRIZIVIR
Chemical Type: 3
Therapeutic Potential: P
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
OTC/RX Status: RX
Indication(s): Provides for the use of Trizivir either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection
Original Application #: 021135
Approval Date: 06-NOV-00
Trade Name: VENOFER
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: LUITPOLD PHARMACEUTICALS INC
Active Ingredient(s): IRON SUCROSE
OTC/RX Status: RX
Indication(s): For the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy
Efficacy Supplemental New Drug Applications
Application #: 021087 Efficacy Supplement#: 002
Type: SE1 to Original New Drug Application
Approval Date: 17-NOV-00
Trade Name: TAMIFLU
Dosage Form: CAPSULE
Applicant: HOFFMANN LA ROCHE INC
Active Ingredient(s): OSELTAMIVIR PHOSPHATE
OTC/RX Status: RX
Efficacy Claim: For the prophylaxis of influenza virus in adults and adolescents 13 years and older
Application #: 020164 Efficacy Supplement#: 036
Type: SE1 to Original New Drug Application
Approval Date: 17-NOV-00
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Efficacy Claim: For the thromboprophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness
Application #: 020592 Efficacy Supplement #: 011
Type: SE1 to Original New Drug Application
Approval Date: 09-NOV-00
Trade Name: ZYPREXA
Dosage Form: TABLET
Applicant: ELI LILLY AND CO
Active Ingredient(s): OLANZAPINE
OTC/RX Status: RX
Efficacy Claim:
Approvable Original New Drug Applications
Original Abbreviated Application # 075703
Approval Date: 27-NOV-00
Trade Name: CLEMASTINE FUMARATE
Dosage Form: SYRUP
Applicant: NOVEX PHARMA
Active Ingredient(s): CLEMASTINE FUMARATE
OTC/RX Status: RX
Original Abbreviated Application # 040395
Approval Date: 27-NOV-00
Trade Name: DIPHENOXYLATE HCL AND ATROPINE SULFATE
Dosage Form: TABLET
Applicant: ABLE LABORATORIES INC
Active Ingredient(s): DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULFATE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065059
Approval Date: 24-NOV-00
Trade Name: AMOXICILLIN
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): AMOXICILLIN
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065053
Approval Date: 22-NOV-00
Trade Name: DOXYCYCLINE
Dosage Form: CAPSULE
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX
Original Abbreviated Application # 040253
Approval Date: 22-NOV-00
Trade Name: ETHOSUXIMIDE
Dosage Form: SYRUP
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): ETHOSUXIMIDE
OTC/RX Status: RX
Original Abbreviated Application # 075518
Approval Date: 17-NOV-00
Trade Name: MINOXIDIL (FOR MEN)
Dosage Form: SOLUTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC
Original Abbreviated Application # 075619
Approval Date: 17-NOV-00
Trade Name: MINOXIDIL
Dosage Form: SOLUTION
Applicant: COPLEY PHARMACEUTICAL INC
Active Ingredient(s): MINOXIDIL
OTC/RX Status: OTC
Original Abbreviated Application # 075643
Approval Date: 16-NOV-00
Trade Name: BISOPROLOL FUMARATE
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): BISOPROLOL FUMARATE
OTC/RX Status: RX
Original Abbreviated Application # 040379
Approval Date: 15-NOV-00
Trade Name: FLUOROURACIL
Dosage Form: INJECTABLE
Applicant: BIGMAR INC
Active Ingredient(s): FLUOROURACIL
OTC/RX Status: RX
Original Abbreviated Application # 075561
Approval Date: 14-NOV-00
Trade Name: CHLORHEXIDINE GLUCONATE
Dosage Form: SOLUTION
Applicant: NOVEX PHARMA
Active Ingredient(s): CHLORHEXIDINE GLUCONATE
OTC/RX Status: RX
Original Abbreviated Application # 074713
Approval Date: 14-NOV-00
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX
Original Abbreviated Application # 075663
Approval Date: 07-NOV-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: IMPAX PHARMACEUTICALS
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075036
Approval Date: 07-NOV-00
Trade Name: CISPLATIN
Dosage Form: INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): CISPLATIN
OTC/RX Status: RX
Original Abbreviated Application # 075620
Approval Date: 01-NOV-00
Trade Name: MIDAZOLAM HCL
Dosage Form: INJECTABLE
Applicant: APOTHECON INC DIV BRISTOL MYERS SQUIBB
Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075806
Tentative Approval Date: 15-NOV-00
Trade Name: NIZATIDINE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): NIZATIDINE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020388 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 29-NOV-00
Trade Name: NAVELBINE
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME, INC.
Active Ingredient(s): VINORELBINE TARTRATE
OTC/RX Status: RX
Application #: 018936 Labeling Supplement #: 063
To Original New Drug Application
Approval Date: 28-NOV-00
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018936 Labeling Supplement #: 062
To Original New Drug Application
Approval Date: 28-NOV-00
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018936 Labeling Supplement #: 060
To Original New Drug Application
Approval Date: 28-NOV-00
Trade Name: PROZAC
Dosage Form: CAPSULE
Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020044 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 21-NOV-00
Trade Name: EXOSURF NEONATAL
Dosage Form:SUSPENSION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): COLFOSCERIL PALMITATE; CETYL ALCOHOL; TYLOXAPOL
OTC/RX Status: RX
Application #: 020164 Labeling Supplement#: 037
To Original New Drug Application
Approval Date: 17-NOV-00
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICALS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Application #: 020990 Labeling Supplement #: 006
To Original New Drug Application
Approval Date: 16-NOV-00
Trade Name: ZOLOFT
Dosage Form: CONCENTRATE
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019839 Labeling Supplement #: 038
To Original New Drug Application
Approval Date: 16-NOV-00
Trade Name: ZOLOFT
Dosage Form: TABLET
Applicant: PFIZER PHARMACEUTICALS INC
Active Ingredient(s): SERTRALINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020628 Labeling Supplement #: 014
To Original New Drug Application
Approval Date: 14-NOV-00
Trade Name: INVIRASE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): SAQUINAVIR MESYLATE
OTC/RX Status: RX
Application #: 020828 Labeling Supplement #: 008
To Original New Drug Application
Approval Date: 13-NOV-00
Trade Name: FORTOVASE
Dosage Form: CAPSULE
Applicant: HLR TECHNOLOGY
Active Ingredient(s): SAQUINAVIR
OTC/RX Status: RX
Application #: 020934 Labeling Supplement #: 001
To Original New Drug Application
Approval Date: 12-NOV-00
Trade Name: LUXIQ
Dosage Form: AEROSOL
Applicant: CONNETICS CORP
Active Ingredient(s): BETAMETHASONE VALERATE
OTC/RX Status: RX
Application #: 020933 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 06-NOV-00
Trade Name: VIRAMUNE
Dosage Form: SUSPENSION
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Application #: 020740 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 06-NOV-00
Trade Name: BAYCOL
Dosage Form: TABLET
Applicant: BAYER CORP PHARMACEUTICAL DIV
Active Ingredient(s): CERIVASTATIN SODIUM
OTC/RX Status: RX
Application #: 020636 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 06-NOV-00
Trade Name: VIRAMUNE
Dosage Form: TABLET
Applicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Active Ingredient(s): NEVIRAPINE
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 026
To Original New Drug Application
Approval Date: 01-NOV-00
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
Application #: 019813 Labeling Supplement#: 025
To Original New Drug Application
Approval Date: 01-NOV-00
Trade Name: DURAGESIC
Dosage Form: FILM, CONTROLLED RELEASE
Applicant: ALZA CORP
Active Ingredient(s): FENTANYL
OTC/RX Status: RX
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Date created: March 08, 2001; last updated: June 20, 2005 |
