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Drug Approvals for January 2002
Definitions and Notes
Original New Drug Applications
Efficacy Supplemental New Drug Applications
Application #: 020837 Efficacy Supplement #: 006
Type: SE5 to Original New Drug Application
Approval Date: 30-JAN-02
Trade Name: XOPENEX
Dosage Form: SOLUTION
Applicant: SEPRACOR, INC
Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE
OTC/RX Status: RX
Efficacy Claim:For the treatment or prevention of bronchospasm in children 6 years of age and older with reversible obstructive airway disease
Application #: 021183 Efficacy Supplement #: 002
Type: SE8 to Original New Drug Application
Approval Date: 29-JAN-02
Trade Name: VIDEX EC
Dosage Form: CAPSULE
Applicant: BRISTOL MYERS SQUIBB
Active Ingredient(s): DIDANOSINE
OTC/RX Status: RX
Efficacy Claim: In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults
Application #: 021226 Efficacy Supplement#: 003
Type: SE8 to Original New Drug Application
Approval Date: 18-JAN-02
Trade Name: KALETRA
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR;RITONAVIR
OTC/RX Status: RX
Efficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021226 Efficacy Supplement#: 004
Type: SE8 to Original New Drug Application
Approval Date: 18-JAN-02
Trade Name: KALETRA
Dosage Form: CAPSULE
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR;RITONAVIR
OTC/RX Status: RX
Efficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021251 Efficacy Supplement#: 003
Type: SE8 to Original New Drug Application
Approval Date: 18-JAN-02
Trade Name: KALETRA
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR;RITONAVIR
OTC/RX Status: RX
Efficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021251 Efficacy Supplement#: 004
Type: SE8 to Original New Drug Application
Approval Date: 18-JAN-02
Trade Name: KALETRA
Dosage Form: SOLUTION
Applicant: ABBOTT LABORATORIES
Active Ingredient(s): LOPINAVIR;RITONAVIR
OTC/RX Status: RX
Efficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Approvable Original New Drug Applications
Original Abbreviated Antibiotic Application # 065067
Approval Date: 31-JAN-02
Trade Name: CLINDAMYCIN PHOSPHATE
Dosage Form: SUSPENSION
Applicant: ALTANA INC
Active Ingredient(s): CLINDAMYCIN PHOSPHATE
OTC/RX Status: RX
Original Abbreviated Application # 075245
Approval Date: 31-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: IVAX PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075690
Approval Date: 31-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: SOLUTION
Applicant: ALPHARMA USPD INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075464
Approval Date: 30-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: SIEGFRIED LTD
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075207
Approval Date: 30-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076006
Approval Date: 30-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076022
Approval Date: 30-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: CARLSBAD TECHNOLOGY INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076015
Approval Date: 30-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: SOLUTION
Applicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076024
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 076001
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: SIDMAK LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075969
Approval Date: 29-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: ALPHAPHARM PHARMACEUTICAL
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075967
Approval Date: 29-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075920
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: SOLUTION
Applicant: MALLINCKRODT INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075872
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075807
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE HCL
Dosage Form: CAPSULE
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075787
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: MUTUAL PHARMACAL CO
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075662
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075658
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: MALLINCKRODT INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075600
Approval Date: 29-JAN-02
Trade Name: PODOFILOX
Dosage Form: SOLUTION
Applicant: PADDOCK LABORATORIES INC
Active Ingredient(s): PODOFILOX
OTC/RX Status: RX
Original Abbreviated Application # 075577
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: ALPHAPHARM PARTY LTD
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075465
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: DR REDDYS LABORATORIES LTD
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075452
Approval Date: 29-JAN-02
Trade Name: FLUOXETINE
Dosage Form: CAPSULE
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): FLUOXETINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 040436
Approval Date: 29-JAN-02
Trade Name: DEXTROAMPHETAMINE SULFATE
Dosage Form: TABLET
Applicant: MALLINCKRODT INC
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Original Abbreviated Application # 075190
Approval Date: 28-JAN-02
Trade Name: PACLITAXEL
Dosage Form:INJECTABLE
Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Original Abbreviated Application # 075985
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORP
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075978
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075973
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: GENPHARM INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075971
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant:BARR LABORATORIES, INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075965
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075961
Approval Date: 25-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: ANDRX PHARMACEUTICALS INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075184
Approval Date: 25-JAN-02
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: IVAX RESEARCH, INC
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Original Abbreviated Application # 076033
Approval Date: 24-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075979
Approval Date: 24-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: WATSON LABORATORIES INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075976
Approval Date: 24-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075975
Approval Date: 24-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: ZENITH GOLDLINE PHARMACEUTICALS INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075972
Approval Date: 24-JAN-02
Trade Name: METFORMIN HCL
Dosage Form: TABLET
Applicant: GOLDLINE LABORATORIES INC
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075762
Approval Date: 16-JAN-02
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 # 075339
Approval Date: 11-JAN-02
Trade Name: SULFASALAZINE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX
Original Abbreviated Application # 075784
Approval Date: 11-JAN-02
Trade Name: KETOROLAC TROMETHAMINE
Dosage Form: INJECTABLE
Applicant: AMERICAN PHARMACEUTICAL PARTNERS INC
Active Ingredient(s): KETOROLAC TROMETHAMINE
OTC/RX Status: RX
Original Abbreviated Application # 040349
Approval Date: 11-JAN-02
Trade Name: SULFASALAZINE
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): SULFASALAZINE
OTC/RX Status: RX
Original Abbreviated Application # 075912
Approval Date: 10-JAN-02
Trade Name: KETOCONAZOLE
Dosage Form: TABLET
Applicant: TORPHARM INC
Active Ingredient(s): KETOCONAZOLE
OTC/RX Status: RX
Original Abbreviated Application # 076012
Approval Date: 09-JAN-02
Trade Name: BUPIVACINE HCL
Dosage Form: INJECTABLE
Applicant: INTERNATIONAL MEDICATED SYSTEMS LTD
Active Ingredient(s): BUPIVACAINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075910
Approval Date: 07-JAN-02
Trade Name: DICLOFENAC SODIUM
Dosage Form: TABLET
Applicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INC
Active Ingredient(s): DICLOFENAC SODIUM
OTC/RX Status: RX
Original Abbreviated Application # 075250
Approval Date: 04-JAN-02
Trade Name: PREDNISOLONE SODIUM PHOSPHATE
Dosage Form: SOLUTION
Applicant: WE PHARMACEUTICALS INC
Active Ingredient(s): PREDNISOLONE SODIUM PHOSPHATE
OTC/RX Status: RX
Original Abbreviated Application # 040377
Approval Date: 04-JAN-02
Trade Name: PHENTERMINE HCL
Dosage Form: TABLET
Applicant: VINTAGE PHARMACEUTICALS INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application # 075844
Approval Date: 03-JAN-02
Trade Name: OXAPROZIN
Dosage Form: TABLET
Applicant: CARACO PHARMACEUTICAL LABORATORIES LTD
Active Ingredient(s): OXAPROZIN
OTC/RX Status: RX
Original Abbreviated and 505(b)(2) New Drug Applications with Tentative Approval
Original Abbreviated Application #: 075297
Tentative Approval Date: 24-JAN-02
Trade Name: PACLITAXEL
Dosage Form: INJECTABLE
Applicant: IVAX PHARMACEUTICALS, INC
Active Ingredient(s): PACLITAXEL
OTC/RX Status: RX
Original Abbreviated Application #: 075932
Tentative Approval Date: 24-JAN-02
Trade Name: BUPROPRION HCL
Dosage Form: TABLET
Applicant: EON LABORATORIES MANUFACTURING INC
Active Ingredient(s): BUPROPION HYDROCHLORIDE
OTC/RX Status: RX
Original Abbreviated Application #: 076137
Tentative Approval Date: 18-JAN-02
Trade Name: DEXTROAMPHETAMINE SULFATE
Dosage Form: CAPLET, EXTENDED RELEASE
Applicant: BARR LABORATORIES, INC
Active Ingredient(s): DEXTROAMPHETAMINE SULFATE
OTC/RX Status: RX
Original Abbreviated Application #: 076180
Tentative Approval Date: 18-JAN-02
Trade Name: LISINOPRIL
Dosage Form: TABLET
Applicant: PUREPACK PHARMACEUTICAL CO.
Active Ingredient(s):LISINOPRIL
OTC/RX Status: RX
Original Abbreviated Application #: 076119
Tentative Approval Date: 15-JAN-02
Trade Name: MIRTAZAPINE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA INC
Active Ingredient(s): MIRTAZAPINE
OTC/RX Status: RX
Original Abbreviated Application #: 075977
Tentative Approval Date: 15-JAN-02
Trade Name: TRAMADOL HYDROCHLORIDE
Dosage Form: TABLET
Applicant: TEVA PHARMACEUTICALS USA
Active Ingredient(s): TRAMADOL
OTC/RX Status: RX
Original Abbreviated Application #: 076113
Tentative Approval Date: 07-JAN-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: MYLAN PHARMACEUTICALS INC
Active Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRIL
OTC/RX Status: RX
Original Abbreviated Application #: 076007
Tentative Approval Date: 04-JAN-02
Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDE
Dosage Form: TABLET
Applicant: RANBAXY LABORATORIES LTD
Active Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDE
OTC/RX Status: RX
Labeling Supplements to Original New Drug Applications
Application #: 020902 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 31-JAN-02
Trade Name: PEPCID AC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Application #: 020325 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 31-JAN-02
Trade Name: PEPCID AC
Dosage Form: TABLET
Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC
Active Ingredient(s): FAMOTIDINE
OTC/RX Status: OTC
Application #: 019918 Labeling Supplement#: 009
To Original New Drug Application
Approval Date: 17-JAN-02
Trade Name: NIX
Dosage Form: SHAMPOO
Applicant: WARNER LAMBERT CO CONSUMER PRODUCTS DIV
Active Ingredient(s): PERMETHRIN
OTC/RX Status: OTC
Application #: 020715 Labeling Supplement#: 004
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: TRELSTAR DEPOT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRIPTORELIN PAMOATE
OTC/RX Status: RX
Application #: 020715 Labeling Supplement#: 003
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: TRELSTAR DEPOT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): TRIPTORELIN PAMOATE
OTC/RX Status: RX
Application #: 020553 Labeling Supplement#: 024
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: OXYCONTIN
Dosage Form: TABLET
Applicant: PURDUE PHARMA LP
Active Ingredient(s): OXYCODONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020489 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: ANDRODERM
Dosage Form: FILM
Applicant:THERATECH, INC
Active Ingredient(s): TESTOSTERONE
OTC/RX Status: RX
Application #: 020379 Labeling Supplement#: 011
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: CAVERJECT
Dosage Form: INJECTABLE
Applicant: PHARMACIA AND UPJOHN CO
Active Ingredient(s): ALPROSTADIL
OTC/RX Status: RX
Application #: 020088 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 15-JAN-02
Trade Name: NORPLANT SYSTEM
Dosage Form: IMPLANT
Applicant: WYETH AYERST LABORATORIES
Active Ingredient(s): LEVONORGESTREL
OTC/RX Status: RX
Application #: 019890 Labeling Supplement#: 017
To Original New Drug Application
Approval Date: 14-JAN-02
Trade Name: STADOL
Dosage Form: SPRAY, METERED
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): BUTORPHANOL TARTRATE
OTC/RX Status: RX
Application #: 019758 Labeling Supplement#: 045
To Original New Drug Application
Approval Date: 14-JAN-02
Trade Name: CLOZARIL
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): CLOZAPINE
OTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 032
To Original New Drug Application
Approval Date: 11-JAN-02
Trade Name: RITALIN-SR
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 060
To Original New Drug Application
Approval Date: 11-JAN-02
Trade Name: RITALIN TAB
Dosage Form: TABLET
Applicant: NOVARTIS PHARMACEUTICALS CORP
Active Ingredient(s): METHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 050718 Labeling Supplement #: 010
To Original New Drug Application
Approval Date: 10-JAN-02
Trade Name: DOXIL
Dosage Form: INJECTABLE
Applicant: ALZA CORP
Active Ingredient(s): DOXORUBICIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018261 Labeling Supplement#: 021
To Original New Drug Application
Approval Date: 10-JAN-02
Trade Name: PITOCIN
Dosage Form: INJECTABLE
Applicant: PARKEDALE PHARMACEUTICALS INC
Active Ingredient(s): OXYTOCIN
OTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 046
To Original New Drug Application
Approval Date: 09-JAN-02
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 09-JAN-02
Trade Name: LOVENOX
Dosage Form: INJECTABLE
Applicant: AVENTIS PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 040
To Original New Drug Application
Approval Date: 09-JAN-02
Trade Name: LOVENOX
Dosage Form: INJECT
Applicant: AVENTIS PHARMACEUTICAL PRODUCTS INC
Active Ingredient(s): ENOXAPARIN SODIUM
OTC/RX Status: RX
Application #: 021202 Labeling Supplement #: 003
To Original New Drug Application
Approval Date: 08-JAN-02
Trade Name: GLUCOPHAGE XR
Dosage Form: TABLET, SUSTAINED ACTION
Applicant: BRISTOL MYERS SQUIBB CO
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020357 Labeling Supplement #: 024
To Original New Drug Application
Approval Date: 08-JAN-02
Trade Name: GLUCOPHAGE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): METFORMIN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020152 Labeling Supplement #: 029
To Original New Drug Application
Approval Date: 08-JAN-02
Trade Name: SERZONE
Dosage Form: TABLET
Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
Active Ingredient(s): NEFAZODONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 021073 Labeling Supplement#: 016
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ACTOS
Dosage Form: TABLET
Applicant: TAKEDA PHARMACEUTICALS NORTH AMERICA INC
Active Ingredient(s): PIOGLITAZONE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020251 Labeling Supplement #: 011
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC 150
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020207 Labeling Supplement #: 005
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ALKERAN
Dosage Form: INJECTABLE
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): MELPHALAN HYDROCHLORIDE
OTC/RX Status: RX
Application #: 020095 Labeling Supplement #: 013
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC 150
Dosage Form: CAPSULE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019675 Labeling Supplement #: 025
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC
Dosage Form: SYRUP
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019593 Labeling Supplement #: 033
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 019090 Labeling Supplement #: 045
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC
Dosage Form: INJECTABLE
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 018703 Labeling Supplement #: 061
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ZANTAC 150
Dosage Form: TABLET
Applicant: GLAXO WELLCOME INC
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 014691 Labeling Supplement #: 023
To Original New Drug Application
Approval Date: 07-JAN-02
Trade Name: ALKERAN
Dosage Form: TABLET
Applicant: GLAXOSMITHKLINE
Active Ingredient(s): MELPHALAN
OTC/RX Status: RX
Application #: 021278 Labeling Supplement#: 001
To Original New Drug Application
Approval Date: 03-JAN-02
Trade Name: FOCALIN
Dosage Form: TABLET
Applicant: NOVARTIS PHAMACEUTICALS CORPORATION
Active Ingredient(s): DEXMETHYLPHENIDATE HYDROCHLORIDE
OTC/RX Status: RX
Application #: 017090 Labeling Supplement#: 067
To Original New Drug Application
Approval Date: 03-JAN-02
Trade Name: TOFRANIL-PM
Dosage Form: CAPSULE
Applicant: MALLINCKRODT INC.
Active Ingredient(s): IMIPRAMINE PAMOATE
OTC/RX Status: RX
Application #: 011909 Labeling Supplement#: 030
To Original New Drug Application
Approval Date: 03-JAN-02
Trade Name: NARDIL
Dosage Form: TABLET
Applicant: PFIZER INC
Active Ingredient(s): PHENELZINE SULFATE
OTC/RX Status: RX
Application #: 020895 Labeling Supplement#: 012
To Original New Drug Application
Approval Date: 02-JAN-02
Trade Name: VIAGRA
Dosage Form: TABLET
Applicant: PFIZER AGRICULTURAL DIV
Active Ingredient(s): SILDENAFIL CITRATE
OTC/RX Status: RX
Application #: 020450 Labeling Supplement#: 007
To Original New Drug Application
Approval Date: 02-JAN-02
Trade Name: CEREBYX
Dosage Form: INJECTABLE
Applicant: PARKE DAVIS DIV WARNER LAMBERT CO
Active Ingredient(s): FOSPHENYTOIN SODIUM
OTC/RX Status: RX
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Date created: December 07, 2001; last updated: June 20, 2005 |
