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Drug Approvals for December 2000
Definitions and Notes
Original New Drug Applications
Original Application #: 021228
Approval Date: 22-DEC-00
Trade Name: DETROL LA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: CAPSULE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TOLTERODINE TARTRATE
OTC/RX Status: RX
Indication(s): For the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency
Original Application #: 020873
Approval Date: 15-DEC-00
Trade Name: ANGIOMAX
Chemical Type: 1
Therapeutic Potential: S
Dosage Form: INJECTABLE
Applicant: MEDICINES CO (TMC)
Active Ingredient(s): BIVALIRUDIN
OTC/RX Status: RX
Indication(s): As an anticoagulant in conjunction with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA)
Original Application #: 050777
Approval Date: 08-DEC-00
Trade Name: PROTOPIC
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: OINTMENT
Applicant: FUJISAWA HEALTHCARE INC
Active Ingredient(s): TACROLIMUS
OTC/RX Status: RX
Indication(s): For short term and intermittent, long term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies
Original Application #: 020010
Approval Date: 08-DEC-00
Trade Name: LOTRISONE
Chemical Type: 34
Therapeutic Potential: S
Dosage Form: LOTION
Applicant: SCHERING CORP SUB SCHERING PLOUGH CORP
Active Ingredient(s): BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
OTC/RX Status: RX
Indication(s): For the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum
Original Application #: 021225
Approval Date: 06-DEC-00
Trade Name: MIRENA
Chemical Type: 3
Therapeutic Potential: S
Dosage Form: DEVICE
Applicant: BERLEX LABORATORIES INC
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX
Indication(s): For intrauterine contraception
Efficacy Supplemental New Drug Applications
Application #: 050759 Efficacy Supplement#: 005
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-00
Trade Name: CELLCEPT
Dosage Form: SUSPENSION
Applicant: ROCHE GLOBAL DEVELOPMENT DIV SYNTEX (USA) LLC
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prevention of acute rejection in pediatric renal transplant patients
Application #: 050723 Efficacy Supplement#: 004
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-00
Trade Name: CELLCEPT
Dosage Form: TABLET
Applicant: ROCHE GLOBAL DEVELOPMENT DIV SYNTEX (USA) LLC
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prevention of acute rejection in pediatric renal transplant patients
Application #: 050722 Efficacy Supplement#: 007
Type: SE5 to Original New Drug Application
Approval Date: 20-DEC-00
Trade Name: CELLCEPT
Dosage Form: CAPSULE
Applicant: ROCHE GLOBAL DEVELOPMENT DIV SYNTEX (USA) LLC
Active Ingredient(s): MYCOPHENOLATE MOFETIL
OTC/RX Status: RX
Efficacy Claim: For the prevention of acute rejection in pediatric renal transplant patients
Application #: 020977 Efficacy Supplement#: 002
Type: SE8 to Original New Drug Application
Approval Date: 15-DEC-00
Trade Name: ZIAGEN
Dosage Form: TABLET
Applicant:GLAXO WELLCOME INC
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX
Efficacy Claim: Is indicated, in combinaton with other antiretroviral agents, for the treatment of HIV-1 infection
Application #: 020978 Efficacy Supplement#: 002
Type: SE8 to Original New Drug Application
Approval Date: 15-DEC-00
Trade Name: ZIAGEN
Dosage Form: SOLUTION
Applicant:GLAXO WELLCOME INC
Active Ingredient(s): ABACAVIR SULFATE
OTC/RX Status: RX
Efficacy Claim: Is indicated, in combinaton with other antiretroviral agents, for the treatment of HIV-1 infection
Application #: 020641 Efficacy Supplement#: 007
Type: SE5 to Original New Drug Application
Approval Date: 04-DEC-00
Trade Name: CLARITIN
Dosage Form: SYRUP
Applicant: SCHERING CORP
Active Ingredient(s): LORATADINE
OTC/RX Status: RX
Efficacy Claim: For the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 years of age and older
Application #: 020865 Efficacy Supplement#: 006
Type: SE8 to Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT MLT
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK & CO, INC
Active Ingredient(s): RIZATRIPTAN
OTC/RX Status: RX
Efficacy Claim: For the acute treatment of migraine attacks with or without aura in adults
Application #: 020864 Efficacy Supplement#: 005
Type: SE8 to Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK & CO, INC
Active Ingredient(s): RIZATRIPTAN
OTC/RX Status: RX
Efficacy Claim: For the acute treatment of migraine attacks with or without aura in adults
Approvable Original New Drug Applications
Original Abbreviated Antibiotic Application# 065044
Approval Date: 20-DEC-00
Trade Name: CYCLOSPORINE
Dosage Form: CAPSULE
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): CYCLOSPORINE
OTC/RX Status: RX
Original Abbreviated Application # 075725
Approval Date: 19-DEC-00
Trade Name: SOTALOL HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): SOTALOL HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075379
Approval Date: 15-DEC-00
Trade Name: VALPROIC ACID
Dosage Form: SYRUP
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): VALPROIC ACID
OTC/RX Status: RX
Original Abbreviated Application # 075117
Approval Date: 14-DEC-00
Trade Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form: SOLUTION
Applicant: ASCENT PEDIATRICS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX
Original Abbreviated Application # 075269
Approval Date: 04-DEC-00
Trade Name: NIFEDIPINE
Dosage Form: TABLET, EXTENDED RELEASE
Applicant: BIOVAIL LABORATORIES INC
Active Ingredient(s): NIFEDIPINE
OTC/RX Status: RX
Original Abbreviated Application # 075384
Approval Date: 01-DEC-00
Trade Name: TERAZOSIN HCL
Dosage Form: CAPSULE
Applicant: BERTEK INC
Active Ingredient(s): TERAZOSIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065055
Approval Date: 01-DEC-00
Trade Name: DOXYCYCLINE
Dosage Form: CAPSULE
Applicant: PAR PHARMACEUTICAL INC
Active Ingredient(s): DOXYCYCLINE
OTC/RX Status: RX
Original Abbreviated Application # 040295
Approval Date: 01-DEC-00
Trade Name: HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Dosage Form: TABLET
Applicant: AMIDE PHARMACEUTICAL INC
Active Ingredient(s): HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075705
Tentative Approval Date: 12-DEC-00
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Original Abbreviated Application #: 075669
Tentative Approval Date: 12-DEC-00
Trade Name: FAMOTIDINE
Dosage Form: INJECTABLE
Applicant: FAULDING PHARMACEUTICAL CO
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020597 Labeling Supplement#: 014
To Original New Drug Application
Approval Date: 26-DEC-00
Trade Name: XALATAN
Dosage Form: SOLUTION, DROPS
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): LATANOPROST
OTC/RX Status: RX
Application #: 021039 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 19-DEC-00
Trade Name: AGENERASE
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): AMPRENAVIR
OTC/RX Status: RX
Application #: 020903 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 18-DEC-00
Trade Name: REBETOL
Dosage Form: CAPSULE
Applicant: SCHERING PLOUGH RESEARCH INSTITUTE
Active Ingredient(s): RIBAVIRIN
OTC/RX Status: RX
Application #: 020103 Labeling Supplement#: 018
To Original New Drug Application
Approval Date: 13-DEC-00
Trade Name: ZOFRAN
Dosage Form: TABLET
Applicant: GLAXO WELLCOME, INC.
Active Ingredient(s): ONDANSETRON
OTC/RX Status: RX
Application #: 020605 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 13-DEC-00
Trade Name: ZOFRAN
Dosage Form: SOLUTION
Applicant: GLAXO WELLCOME, INC.
Active Ingredient(s): ONDANSETRON
OTC/RX Status: RX
Application #: 020781 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 13-DEC-00
Trade Name: ZOFRAN
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: GLAXO WELLCOME, INC.
Active Ingredient(s): ONDANSETRON
OTC/RX Status: RX
Application #: 020459 Labeling Supplement#: 002
To Original New Drug Application
Approval Date: 12-DEC-00
Trade Name: REVEX
Dosage Form: INJECTABLE
Applicant: BAXTER PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): NALMEFENE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020865 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT-MLT
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Application #: 020865 Labeling Supplement#: 005
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT-MLT
Dosage Form: TABLET, ORALLY DISINTEGRATING
Applicant: MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Application #: 020864 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Application #: 020864 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: MAXALT
Dosage Form: TABLET
Applicant: MERCK AND CO INC
Active Ingredient(s): RIZATRIPTAN BENZOATE
OTC/RX Status: RX
Application #: 020626 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: IMITREX
Dosage Form: SPRAY
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): SUMATRIPTAN
OTC/RX Status: RX
Application #: 012516 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: SANSERT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYSERGIDE MALEATE
OTC/RX Status: RX
Application #: 012516 Labeling Supplement#: 041
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: SANSERT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYSERGIDE MALEATE
OTC/RX Status: RX
Application #: 012516 Labeling Supplement#: 038
To Original New Drug Application
Approval Date: 11-DEC-00
Trade Name: SANSERT
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYSERGIDE MALEATE
OTC/RX Status: RX
Application #: 020998 Labeling Supplement#: 008
To Original New Drug Application
Approval Date: 01-DEC-00
Trade Name: CELEBREX
Dosage Form: CAPSULE
Applicant: GD SEARLE AND CO
Active Ingredient(s): CELECOXIB
OTC/RX Status: RX
Application #: 020460 Labeling Supplement#: 010
To Original New Drug Application
Approval Date: 01-DEC-00
Trade Name: CYTOVENE
Dosage Form: CAPSULE
Applicant: SYNTEX (USA) LLC
Active Ingredient(s): GANCICLOVIR
OTC/RX Status: RX
Application #: 019661 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 01-DEC-00
Trade Name: CYTOVENE IV
Dosage Form: INJECTABLE
Applicant: SYNTEX (USA) LLC
Active Ingredient(s): GANCICLOVIR SODIUM
OTC/RX Status: RX
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Date created: March 08, 2001; last updated; June 20, 2005 |
