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FDA
Food and Drug Administration
Farmaci Autorizzati nel
Primo Trimestre 2002
Gennaio 2002
Febbraio 2002
Marzo 2002
FDA - FARMACI AUTORIZZATI NEL PRIMO TRIMESTRE 2002 02/05/2002
file:///C|/COPIA/fda22.htm [30/04/2002 15.37.43]
Drug Approvals for January 2002
Definitions and Notes
Original New Drug Applications
Efficacy Supplemental New Drug Applications
Application #: 020837 Efficacy Supplement #: 006Type: SE5 to Original New Drug ApplicationApproval Date: 30-JAN-02Trade Name: XOPENEXDosage Form: SOLUTIONApplicant: SEPRACOR, INCActive Ingredient(s): LEVALBUTEROL HYDROCHLORIDEOTC/RX Status: RXEfficacy Claim:For the treatment or prevention of bronchospasm in children 6 years of age and older withreversible obstructive airway disease
Application #: 021226 Efficacy Supplement#: 003Type: SE8 to Original New Drug ApplicationApproval Date: 18-JAN-02Trade Name: KALETRADosage Form: CAPSULEApplicant: ABBOTT LABORATORIESActive Ingredient(s): LOPINAVIR;RITONAVIROTC/RX Status: RXEfficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021226 Efficacy Supplement#: 004Type: SE8 to Original New Drug ApplicationApproval Date: 18-JAN-02Trade Name: KALETRA
FDA Drug Approvals List January 2002
http://www.fda.gov/cder/da/da0102.htm (1 di 21) [30/04/2002 15.31.22]
Dosage Form: CAPSULEApplicant: ABBOTT LABORATORIESActive Ingredient(s): LOPINAVIR;RITONAVIROTC/RX Status: RXEfficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021251 Efficacy Supplement#: 003Type: SE8 to Original New Drug ApplicationApproval Date: 18-JAN-02Trade Name: KALETRADosage Form: SOLUTIONApplicant: ABBOTT LABORATORIESActive Ingredient(s): LOPINAVIR;RITONAVIROTC/RX Status: RXEfficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Application #: 021251 Efficacy Supplement#: 004Type: SE8 to Original New Drug ApplicationApproval Date: 18-JAN-02Trade Name: KALETRADosage Form: SOLUTIONApplicant: ABBOTT LABORATORIESActive Ingredient(s): LOPINAVIR;RITONAVIROTC/RX Status: RXEfficacy Claim:For use with other antiretroviral agents for the treatment of HIV-infection
Approvable Original New Drug Applications
Original Abbreviated New Drug Applications
Original Abbreviated Antibiotic Application # 065067Approval Date: 31-JAN-02Trade Name: CLINDAMYCIN PHOSPHATEDosage Form: SUSPENSIONApplicant: ALTANA INCActive Ingredient(s): CLINDAMYCIN PHOSPHATEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 075245Approval Date: 31-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: IVAX PHARMACEUTICALS INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075690Approval Date: 31-JAN-02Trade Name: FLUOXETINE HCLDosage Form: SOLUTIONApplicant: ALPHARMA USPD INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075464Approval Date: 30-JAN-02Trade Name: FLUOXETINE HCLDosage Form: CAPSULEApplicant: SIEGFRIED LTDActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075207Approval Date: 30-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: MYLAN PHARMACEUTICALS INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 076006Approval Date: 30-JAN-02Trade Name: FLUOXETINE HCLDosage Form: TABLETApplicant: DR REDDYS LABORATORIES LTDActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 076022Approval Date: 30-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: CARLSBAD TECHNOLOGY INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 076015Approval Date: 30-JAN-02Trade Name: FLUOXETINE HCLDosage Form: SOLUTIONApplicant: PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTSActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 076024Approval Date: 29-JAN-02Trade Name: FLUOXETINE HCLDosage Form: TABLETApplicant: EON LABORATORIES MANUFACTURING INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 076001Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: SIDMAK LABORATORIES INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075969Approval Date: 29-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: ALPHAPHARM PHARMACEUTICALActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 075967Approval Date: 29-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: CARACO PHARMACEUTICAL LABORATORIES LTDActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075920Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: SOLUTIONApplicant: MALLINCKRODT INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075872Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: TABLETApplicant: TEVA PHARMACEUTICALS USA INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075807Approval Date: 29-JAN-02Trade Name: FLUOXETINE HCLDosage Form: CAPSULEApplicant: EON LABORATORIES MANUFACTURING INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075787Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: MUTUAL PHARMACAL COActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 075662Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: WATSON LABORATORIES INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075658Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: MALLINCKRODT INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075600Approval Date: 29-JAN-02Trade Name: PODOFILOXDosage Form: SOLUTIONApplicant: PADDOCK LABORATORIES INCActive Ingredient(s): PODOFILOXOTC/RX Status: RX
Original Abbreviated Application # 075577Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: ALPHAPHARM PARTY LTDActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075465Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: DR REDDYS LABORATORIES LTDActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 075452Approval Date: 29-JAN-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: TEVA PHARMACEUTICALS USA INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 040436Approval Date: 29-JAN-02Trade Name: DEXTROAMPHETAMINE SULFATEDosage Form: TABLETApplicant: MALLINCKRODT INCActive Ingredient(s): DEXTROAMPHETAMINE SULFATEOTC/RX Status: RX
Original Abbreviated Application # 075190Approval Date: 28-JAN-02Trade Name: PACLITAXELDosage Form:INJECTABLEApplicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INCActive Ingredient(s): PACLITAXELOTC/RX Status: RX
Original Abbreviated Application # 075985Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: GENEVA PHARMACEUTICALS TECHNOLOGY CORPActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075978Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: TEVA PHARMACEUTICALS USAActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 075973Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: GENPHARM INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075971Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant:BARR LABORATORIES, INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075965Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: EON LABORATORIES MANUFACTURING INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075961Approval Date: 25-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: ANDRX PHARMACEUTICALS INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075184Approval Date: 25-JAN-02Trade Name: PACLITAXELDosage Form: INJECTABLEApplicant: IVAX RESEARCH, INCActive Ingredient(s): PACLITAXELOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 076033Approval Date: 24-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075979Approval Date: 24-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: WATSON LABORATORIES INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075976Approval Date: 24-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: MYLAN PHARMACEUTICALS INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075975Approval Date: 24-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: ZENITH GOLDLINE PHARMACEUTICALS INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075972Approval Date: 24-JAN-02Trade Name: METFORMIN HCLDosage Form: TABLETApplicant: GOLDLINE LABORATORIES INCActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
http://www.fda.gov/cder/da/da0102.htm (9 di 21) [30/04/2002 15.31.23]
Original Abbreviated Application # 075762Approval Date: 16-JAN-02Trade Name: OFLOXACINDosage Form: INJECTABLEApplicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INCActive Ingredient(s): OFLOXACINOTC/RX Status: RX
Original Abbreviated Application # 075339Approval Date: 11-JAN-02Trade Name: SULFASALAZINEDosage Form: TABLETApplicant: VINTAGE PHARMACEUTICALS INCActive Ingredient(s): SULFASALAZINEOTC/RX Status: RX
Original Abbreviated Application # 075784Approval Date: 11-JAN-02Trade Name: KETOROLAC TROMETHAMINEDosage Form: INJECTABLEApplicant: AMERICAN PHARMACEUTICAL PARTNERS INCActive Ingredient(s): KETOROLAC TROMETHAMINEOTC/RX Status: RX
Original Abbreviated Application # 040349Approval Date: 11-JAN-02Trade Name: SULFASALAZINEDosage Form: TABLETApplicant: VINTAGE PHARMACEUTICALS INCActive Ingredient(s): SULFASALAZINEOTC/RX Status: RX
Original Abbreviated Application # 075912Approval Date: 10-JAN-02Trade Name: KETOCONAZOLEDosage Form: TABLETApplicant: TORPHARM INCActive Ingredient(s): KETOCONAZOLEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated Application # 076012Approval Date: 09-JAN-02Trade Name: BUPIVACINE HCLDosage Form: INJECTABLEApplicant: INTERNATIONAL MEDICATED SYSTEMS LTDActive Ingredient(s): BUPIVACAINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075910Approval Date: 07-JAN-02Trade Name: DICLOFENAC SODIUMDosage Form: TABLETApplicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INCActive Ingredient(s): DICLOFENAC SODIUMOTC/RX Status: RX
Original Abbreviated Application # 075250Approval Date: 04-JAN-02Trade Name: PREDNISOLONE SODIUM PHOSPHATEDosage Form: SOLUTIONApplicant: WE PHARMACEUTICALS INCActive Ingredient(s): PREDNISOLONE SODIUM PHOSPHATEOTC/RX Status: RX
Original Abbreviated Application # 040377Approval Date: 04-JAN-02Trade Name: PHENTERMINE HCLDosage Form: TABLETApplicant: VINTAGE PHARMACEUTICALS INCActive Ingredient(s): PHENTERMINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075844Approval Date: 03-JAN-02Trade Name: OXAPROZINDosage Form: TABLETApplicant: CARACO PHARMACEUTICAL LABORATORIES LTDActive Ingredient(s): OXAPROZINOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Original Abbreviated and 505(b)(2) New DrugApplications with Tentative Approval
Original Abbreviated Application #: 075297Tentative Approval Date: 24-JAN-02Trade Name: PACLITAXELDosage Form: INJECTABLEApplicant: IVAX PHARMACEUTICALS, INCActive Ingredient(s): PACLITAXELOTC/RX Status: RX
Original Abbreviated Application #: 075932Tentative Approval Date: 24-JAN-02Trade Name: BUPROPRION HCLDosage Form: TABLETApplicant: EON LABORATORIES MANUFACTURING INCActive Ingredient(s): BUPROPION HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application #: 076137Tentative Approval Date: 18-JAN-02Trade Name: DEXTROAMPHETAMINE SULFATEDosage Form: CAPLET, EXTENDED RELEASEApplicant: BARR LABORATORIES, INCActive Ingredient(s): DEXTROAMPHETAMINE SULFATEOTC/RX Status: RX
Original Abbreviated Application #: 076180Tentative Approval Date: 18-JAN-02Trade Name: LISINOPRILDosage Form: TABLETApplicant: PUREPACK PHARMACEUTICAL CO.Active Ingredient(s):LISINOPRILOTC/RX Status: RX
Original Abbreviated Application #: 076119Tentative Approval Date: 15-JAN-02Trade Name: MIRTAZAPINEDosage Form: TABLET
FDA Drug Approvals List January 2002
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Applicant: TEVA PHARMACEUTICALS USA INCActive Ingredient(s): MIRTAZAPINEOTC/RX Status: RX
Original Abbreviated Application #: 075977Tentative Approval Date: 15-JAN-02Trade Name: TRAMADOL HYDROCHLORIDEDosage Form: TABLETApplicant: TEVA PHARMACEUTICALS USAActive Ingredient(s): TRAMADOLOTC/RX Status: RX
Original Abbreviated Application #: 076113Tentative Approval Date: 07-JAN-02Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDEDosage Form: TABLETApplicant: MYLAN PHARMACEUTICALS INCActive Ingredient(s): HYDROCHLOROTHIAZIDE; LISINOPRILOTC/RX Status: RX
Original Abbreviated Application #: 076007Tentative Approval Date: 04-JAN-02Trade Name: LISINOPRIL AND HYDROCHLOROTHIAZIDEDosage Form: TABLETApplicant: RANBAXY LABORATORIES LTDActive Ingredient(s): LISINOPRIL; HYDROCHLOROTHIAZIDEOTC/RX Status: RX
Labeling Supplements to Original New DrugApplications
Application #: 020902 Labeling Supplement #: 005To Original New Drug ApplicationApproval Date: 31-JAN-02Trade Name: PEPCID ACDosage Form: TABLETApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): FAMOTIDINEOTC/RX Status: OTC
FDA Drug Approvals List January 2002
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Application #: 020325 Labeling Supplement #: 003To Original New Drug ApplicationApproval Date: 31-JAN-02Trade Name: PEPCID ACDosage Form: TABLETApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): FAMOTIDINEOTC/RX Status: OTC
Application #: 019918 Labeling Supplement#: 009To Original New Drug ApplicationApproval Date: 17-JAN-02Trade Name: NIXDosage Form: SHAMPOOApplicant: WARNER LAMBERT CO CONSUMER PRODUCTS DIVActive Ingredient(s): PERMETHRINOTC/RX Status: OTC
Application #: 020715 Labeling Supplement#: 004To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: TRELSTAR DEPOTDosage Form: INJECTABLEApplicant: PHARMACIA AND UPJOHN COActive Ingredient(s): TRIPTORELIN PAMOATEOTC/RX Status: RX
Application #: 020715 Labeling Supplement#: 003To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: TRELSTAR DEPOTDosage Form: INJECTABLEApplicant: PHARMACIA AND UPJOHN COActive Ingredient(s): TRIPTORELIN PAMOATEOTC/RX Status: RX
Application #: 020553 Labeling Supplement#: 024To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: OXYCONTIN
FDA Drug Approvals List January 2002
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Dosage Form: TABLETApplicant: PURDUE PHARMA LPActive Ingredient(s): OXYCODONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 020489 Labeling Supplement#: 007To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: ANDRODERMDosage Form: FILMApplicant:THERATECH, INCActive Ingredient(s): TESTOSTERONEOTC/RX Status: RX
Application #: 020379 Labeling Supplement#: 011To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: CAVERJECTDosage Form: INJECTABLEApplicant: PHARMACIA AND UPJOHN COActive Ingredient(s): ALPROSTADILOTC/RX Status: RX
Application #: 020088 Labeling Supplement#: 016To Original New Drug ApplicationApproval Date: 15-JAN-02Trade Name: NORPLANT SYSTEMDosage Form: IMPLANTApplicant: WYETH AYERST LABORATORIESActive Ingredient(s): LEVONORGESTRELOTC/RX Status: RX
Application #: 019890 Labeling Supplement#: 017To Original New Drug ApplicationApproval Date: 14-JAN-02Trade Name: STADOLDosage Form: SPRAY, METEREDApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEActive Ingredient(s): BUTORPHANOL TARTRATEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Application #: 019758 Labeling Supplement#: 045To Original New Drug ApplicationApproval Date: 14-JAN-02Trade Name: CLOZARILDosage Form: TABLETApplicant: NOVARTIS PHARMACEUTICALS CORPActive Ingredient(s): CLOZAPINEOTC/RX Status: RX
Application #: 018029 Labeling Supplement#: 032To Original New Drug ApplicationApproval Date: 11-JAN-02Trade Name: RITALIN-SRDosage Form: TABLETApplicant: NOVARTIS PHARMACEUTICALS CORPActive Ingredient(s): METHYLPHENIDATE HYDROCHLORIDEOTC/RX Status: RX
Application #: 010187 Labeling Supplement#: 060To Original New Drug ApplicationApproval Date: 11-JAN-02Trade Name: RITALIN TABDosage Form: TABLETApplicant: NOVARTIS PHARMACEUTICALS CORPActive Ingredient(s): METHYLPHENIDATE HYDROCHLORIDEOTC/RX Status: RX
Application #: 050718 Labeling Supplement #: 010To Original New Drug ApplicationApproval Date: 10-JAN-02Trade Name: DOXILDosage Form: INJECTABLEApplicant: ALZA CORPActive Ingredient(s): DOXORUBICIN HYDROCHLORIDEOTC/RX Status: RX
Application #: 018261 Labeling Supplement#: 021To Original New Drug Application
FDA Drug Approvals List January 2002
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Approval Date: 10-JAN-02Trade Name: PITOCINDosage Form: INJECTABLEApplicant: PARKEDALE PHARMACEUTICALS INCActive Ingredient(s): OXYTOCINOTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 046To Original New Drug ApplicationApproval Date: 09-JAN-02Trade Name: LOVENOXDosage Form: INJECTABLEApplicant: AVENTIS PHARMACEUTICAL PRODUCTS INCActive Ingredient(s): ENOXAPARIN SODIUMOTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 045To Original New Drug ApplicationApproval Date: 09-JAN-02Trade Name: LOVENOXDosage Form: INJECTABLEApplicant: AVENTIS PHARMACEUTICAL PRODUCTS INCActive Ingredient(s): ENOXAPARIN SODIUMOTC/RX Status: RX
Application #: 020164 Labeling Supplement #: 040To Original New Drug ApplicationApproval Date: 09-JAN-02Trade Name: LOVENOXDosage Form: INJECTApplicant: AVENTIS PHARMACEUTICAL PRODUCTS INCActive Ingredient(s): ENOXAPARIN SODIUMOTC/RX Status: RX
Application #: 021202 Labeling Supplement #: 003To Original New Drug ApplicationApproval Date: 08-JAN-02Trade Name: GLUCOPHAGE XRDosage Form: TABLET, SUSTAINED ACTIONApplicant: BRISTOL MYERS SQUIBB CO
FDA Drug Approvals List January 2002
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Active Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Application #: 020357 Labeling Supplement #: 024To Original New Drug ApplicationApproval Date: 08-JAN-02Trade Name: GLUCOPHAGEDosage Form: TABLETApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEActive Ingredient(s): METFORMIN HYDROCHLORIDEOTC/RX Status: RX
Application #: 020152 Labeling Supplement #: 029To Original New Drug ApplicationApproval Date: 08-JAN-02Trade Name: SERZONEDosage Form: TABLETApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEActive Ingredient(s): NEFAZODONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 021073 Labeling Supplement#: 016To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ACTOSDosage Form: TABLETApplicant: TAKEDA PHARMACEUTICALS NORTH AMERICA INCActive Ingredient(s): PIOGLITAZONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 020251 Labeling Supplement #: 011To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTAC 150Dosage Form: TABLETApplicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List January 2002
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Application #: 020207 Labeling Supplement #: 005To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ALKERANDosage Form: INJECTABLEApplicant: GLAXOSMITHKLINEActive Ingredient(s): MELPHALAN HYDROCHLORIDEOTC/RX Status: RX
Application #: 020095 Labeling Supplement #: 013To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTAC 150Dosage Form: CAPSULEApplicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 019675 Labeling Supplement #: 025To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTACDosage Form: SYRUPApplicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 019593 Labeling Supplement #: 033To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTACDosage Form: INJECTABLEApplicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 019090 Labeling Supplement #: 045To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTACDosage Form: INJECTABLE
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Applicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 018703 Labeling Supplement #: 061To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ZANTAC 150Dosage Form: TABLETApplicant: GLAXO WELLCOME INCActive Ingredient(s): RANITIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 014691 Labeling Supplement #: 023To Original New Drug ApplicationApproval Date: 07-JAN-02Trade Name: ALKERANDosage Form: TABLETApplicant: GLAXOSMITHKLINEActive Ingredient(s): MELPHALANOTC/RX Status: RX
Application #: 021278 Labeling Supplement#: 001To Original New Drug ApplicationApproval Date: 03-JAN-02Trade Name: FOCALINDosage Form: TABLETApplicant: NOVARTIS PHAMACEUTICALS CORPORATIONActive Ingredient(s): DEXMETHYLPHENIDATE HYDROCHLORIDEOTC/RX Status: RX
Application #: 017090 Labeling Supplement#: 067To Original New Drug ApplicationApproval Date: 03-JAN-02Trade Name: TOFRANIL-PMDosage Form: CAPSULEApplicant: MALLINCKRODT INC.Active Ingredient(s): IMIPRAMINE PAMOATEOTC/RX Status: RX
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Application #: 011909 Labeling Supplement#: 030To Original New Drug ApplicationApproval Date: 03-JAN-02Trade Name: NARDILDosage Form: TABLETApplicant: PFIZER INCActive Ingredient(s): PHENELZINE SULFATEOTC/RX Status: RX
Application #: 020895 Labeling Supplement#: 012To Original New Drug ApplicationApproval Date: 02-JAN-02Trade Name: VIAGRADosage Form: TABLETApplicant: PFIZER AGRICULTURAL DIVActive Ingredient(s): SILDENAFIL CITRATEOTC/RX Status: RX
Application #: 020450 Labeling Supplement#: 007To Original New Drug ApplicationApproval Date: 02-JAN-02Trade Name: CEREBYXDosage Form: INJECTABLEApplicant: PARKE DAVIS DIV WARNER LAMBERT COActive Ingredient(s): FOSPHENYTOIN SODIUMOTC/RX Status: RX
December 07, 200119 Mar 2002 14:30:11 -0500http://www.fda.gov/cder/da/da0102.htm
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Drug Approvals for February 2002
Definitions and Notes
Original New Drug ApplicationsOriginal Application #: 020982Approval Date: 12-FEB-02Trade Name: PAXIL CRChemical Type: 6Therapeutic Potential: SDosage Form: TABLETApplicant: SMITHKLINE BEECHAM PHARMACEUTICALSActive Ingredient(s): PAROXETINE HYDROCHLORIDEOTC/RX Status: RXIndication(s): For the treatment of Panic Disorder
Original Application #: 021363Approval Date: 08-FEB-02Trade Name: CLARINEXChemical Type: 6Therapeutic Potential: SDosage Form: TABLETApplicant: SCHERINGActive Ingredient(s): DESLORATADINEOTC/RX Status: RXIndication(s): For the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients12 years of age and older
Original Application #: 021297Approval Date: 08-FEB-02Trade Name: CLARINEXChemical Type: 6Therapeutic Potential: SDosage Form: TABLETApplicant: SCHERING CORPActive Ingredient(s): DESLORATADINEOTC/RX Status: RXIndication(s): For the symptomatic relief of pruritus, reduction in the number of hives, and size of hives,
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in patients with chronic idipathic urticaria 12 years of age and older
Original Application #: 021360Approval Date: 01-FEB-02Trade Name: SUSTIVAChemical Type: 3Therapeutic Potential: SDosage Form: TABLETApplicant: BRISTOL MYERS SQUIBB PHARMA COActive Ingredient(s): EFAVIRENZOTC/RX Status: RXIndication(s): For the treatment of HIV-1 infection in combination with other antiretrovial agents
Efficacy Supplemental New Drug ApplicationsApplication #: 019643 Efficacy Supplement#: 067Type: SE5 to Original New Drug ApplicationApproval Date: 14-FEB-02Trade Name: MEVACORDosage Form: TABLETApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): LOVASTATINOTC/RX Status: RXEfficacy Claim: For the treatment of heterozygous familial hypercholesterolemia in a new population ofadolescent boys and girls at leat one year postmenarchal, ages 10 to 17 years, with a recommended dosingrange of 10 to 40 mg once daily
Application #: 019810 Efficacy Supplement#: 061Type: SE8 to Original New Drug ApplicationApproval Date: 14-FEB-02Trade Name: PRILOSECDosage Form: CAPSULEApplicant: ASTRAZENECA LPActive Ingredient(s): OMEPRAZOLEOTC/RX Status: RXEfficacy Claim: For the short-term treatment of active duodenal ulcer
Application #: 020811 Efficacy Supplement #: 003Type: SE5 to Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: ACULAR PRESERVATIVE FREEDosage Form: SOLUTION
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Applicant: ALLERGAN INCActive Ingredient(s): KETOROLAC TROMETHAMINEOTC/RX Status: RXEfficacy Claim: For the temporary relief of ocular itching due to seasonal allergic conjunctivitis; for thetreatment of postoperative inflammation in patients who have undergone cataract extraction
Application #: 019700 Efficacy Supplement #: 019Type: SE5 to Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: ACULARDosage Form: SOLUTIONApplicant: ALLERGAN INCActive Ingredient(s): KETOROLAC TROMETHAMINEOTC/RX Status: RXEfficacy Claim:For the temporary relief of ocular itching due to seasonal allergic conjunctivitis; for thetreatment of postoperative inflammation in patients who have undergone cataract extraction
Application #: 020582 Efficacy Supplement #: 006Type: SE1 to Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: FOLLISTIMDosage Form: INJECTABLEApplicant: ORGANON INC SUB AKZONA INCActive Ingredient(s): FOLLITROPIN ALFA/BETAOTC/RX Status: RXEfficacy Claim: For the induction of spermatogenesis in men with primary and secondaryhypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure
Application #: 021335 Efficacy Supplement #: 001Type: SE1 to Original New Drug ApplicationApproval Date: 01-FEB-02Trade Name: GLEEVECDosage Form: CAPSULEApplicant: NOVARTIS PHARMACEUTICALS CORPActive Ingredient(s): IMATINIB MESYLATEOTC/RX Status: RXEfficacy Claim: For the treatment of patients with Kit (CD117) positive unresectable and/or metastaticmalignant gastrointestinal stromal tumors (GIST)
Approvable Original New Drug Applications
Original Application #: 021269Approvable Date: 22-FEB-02
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Trade Name: CARDURA XLDosage Form: TABLET, EXTENDED RELEASEApplicant: PFIZER INCActive Ingredient(s): DOXAZOSIN MESYLATEOTC/RX Status: RX
Original Abbreviated New Drug Applications
Original Abbreviated Application# 075865Approval Date: 28-FEB-02Trade Name: FLUOXETINE HYDROCHLORIDEDosage Form: TABLETApplicant:ZENITH GOLDINE PHARMACEUTICALS INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application# 075022Approval Date: 28-FEB-02Trade Name: BUSPIRONE HYDROCHOLORIDEDosage Form: TABLETApplicant:TEVA PHARMACEUTICALS USAActive Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075948Approval Date: 27-FEB-02Trade Name: CARBAMAZEPINEDosage Form: TABLETApplicant: APOTEX INCActive Ingredient(s): CARBAMAZEPINEOTC/RX Status: RX
Original Abbreviated Antibiotic Application# 075572Approval Date: 27-FEB-02Trade Name: BUSPIRONE HYDROCHOLORIDEDosage Form: TABLETApplicant: KV PHARMACEUTICAL CO.Active Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
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Original Abbreviated Antibiotic Application#065022Approval Date: 27-FEB-02Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATEDosage Form: OINTMENTApplicant: ALTANA INCActive Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATEOTC/RX Status: RX
Original Abbreviated Application# 075874Approval Date: 26-FEB-02Trade Name: IFOSFAMIDE INJECTION/MESNA INJECTION KITDosage Form: INJECTABLEApplicant: GENSIA PHARMACEUTICALS INCActive Ingredient(s): IFOSFAMIDE; MESNAOTC/RX Status: RX
Original Abbreviated Application # 075590Approval Date: 25-FEB-02Trade Name: NABUMETONEDosage Form: TABLET, FILM COATEDApplicant: INVAMED INCActive Ingredient(s): NABUMETONEOTC/RX Status: RX
Original Abbreviated Application # 075280Approval Date: 25-FEB-02Trade Name: NABUMETONEDosage Form: TABLET, FILM COATEDApplicant: EON LABORATORIES MANUFACTURING INCActive Ingredient(s): NABUMETONEOTC/RX Status: RX
Original Abbreviated Application #: 075868Tentative Approval Date: 20-FEB-02Trade Name: FENOFIBRATEDosage Form: CAPSULEApplicant: IMPAX LABORATORIES INCActive Ingredient(s): FENOFIBRATEOTC/RX Status: RX
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Original Abbreviated Application # 076165Approval Date: 15-FEB-02Trade Name: FLUOXETINEDosage Form: CAPSULEApplicant: RANBAXY LABORATORIES LIMITEDActive Ingredient(s): FLUOXETINEOTC/RX Status: RX
Original Abbreviated Application # 075292Approval Date: 07-FEB-02Trade Name: FLUOXETINE HCLDosage Form: SOLUTIONApplicant: NOVEX PHARMAActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075364Approval Date: 07-FEB-02Trade Name: KETOPROFENDosage Form: TABLETApplicant: PERRIGO COActive Ingredient(s): KETOPROFENOTC/RX Status: OTC
Original Abbreviated Application # 076114Approval Date: 06-FEB-02Trade Name: INDOMETHACINDosage Form: CAPSULEApplicant: ABLE LABORATORIES INCActive Ingredient(s): INDOMETHACINOTC/RX Status: RX
Original Abbreviated Application # 076097Approval Date: 06-FEB-02Trade Name: CARTEOLOL HCLDosage Form: SOLUTIONApplicant: NOVEX PHARMAActive Ingredient(s): CARTEOLOL HYDROCHLORIDEOTC/RX Status: RX
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Original Abbreviated Application # 040428Approval Date: 05-FEB-02Trade Name: PROMETHAZINE HCLDosage Form: SUPPOSITORYApplicant: G AND W LABORATORIES INCActive Ingredient(s): PROMETHAZINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 040321Approval Date: 05-FEB-02Trade Name: METHYLPHENIDATE HCLDosage Form: TABLETApplicant: PUREPAC PHARMACEUTICAL CO DIV PUREPAC INCActive Ingredient(s): METHYLPHENIDATE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075810Approval Date: 01-FEB-02Trade Name: FLUOXETINE HCLDosage Form: TABLETApplicant: BARR LABORATORIES INCActive Ingredient(s): FLUOXETINE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated and 505(b)(2) New DrugApplications with Tentative Approval
Original Abbreviated Application# 076153Tentative Approval Date: 28-FEB-02Trade Name: PAMIDRONATE DISODIUMDosage Form: INJECTABLEApplicant: GENSIA SICOR PHARMACEUTICALS INCActive Ingredient(s): PAMIDRONATE DISODIUMOTC/RX Status: RX
Original Abbreviated Application# 075873Tentative Approval Date: 25-FEB-02
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Trade Name: MIDAZOLAM HYDROCHLORIDEDosage Form: SYRUPApplicant: ROXANE LABORATORIES INCActive Ingredient(s): MIDAZOLAM HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application# 076154Tentative Approval Date: 28-FEB-02Trade Name: LORATADINEDosage Form: TABLETApplicant:GENPHARM INCActive Ingredient(s): LORATADINEOTC/RX Status: RX
Original Abbreviated Application #: 075504Tentative Approval Date: 08-FEB-02Trade Name: QUINAPRIL HCLDosage Form: TABLETApplicant: TEVA PHARMACEUTICALS USA INCActive Ingredient(s): QUINAPRIL HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application #: 076059Tentative Approval Date: 05-FEB-02Trade Name: LISINOPRILDosage Form: TABLETApplicant: WATSON LABORATORIES INCActive Ingredient(s): LISINOPRILOTC/RX Status: RX
Original Abbreviated Application #: 075928Tentative Approval Date: 04-FEB-02Trade Name: CIPROFLOXACIN HCLDosage Form: SOLUTIONApplicant: NOVEX PHARMAActive Ingredient(s): CIPROFLOXACIN HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application #: 076067Tentative Approval Date: 01-FEB-02
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Trade Name: MOMETASONE FUROATEDosage Form: OINTMENTApplicant: CLAY-PARK LABS, INCActive Ingredient(s): MOMETASONE FUROATEOTC/RX Status: RX
Labeling Supplements to Original New DrugApplications
Application #: 020825 Labeling Supplement#: 006To Original New Drug ApplicationApproval Date: 15-FEB-02Trade Name: GEODONDosage Form: CAPSULEApplicant: PFIZER CENTRAL RESEARCHActive Ingredient(s): ZIPRASIDONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 019880 Labeling Supplement#: 011To Original New Drug ApplicationApproval Date: 14-FEB-02Trade Name: PARAPLATINDosage Form: INJECTABLEApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEActive Ingredient(s): CARBOPLATINOTC/RX Status: RX
Application #: 016267 Labeling Supplement#: 039To Original New Drug ApplicationApproval Date: 14-FEB-02Trade Name: DESFERALDosage Form: INJECTABLEApplicant: NOVARTIS PHARMACEUTICALS CORPActive Ingredient(s): DEFEROXAMINE MESYLATEOTC/RX Status: RX
Application #: 020936 Labeling Supplement#: 008To Original New Drug ApplicationApproval Date: 12-FEB-02Trade Name: PAXIL CRDosage Form: TABLETApplicant: SMITHKLINE BEECHAM PHARMACEUTICALS
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Active Ingredient(s): PAROXETINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 017936 Labeling Supplement#: 027To Original New Drug ApplicationApproval Date: 11-FEB-02Trade Name: NPH ILETIN I INSULINDosage Form: INJECTABLEApplicant: ELI LILLY AND COActive Ingredient(s): INSULIN SUSP ISOPHANE BEEF/PORKOTC/RX Status: OTC
Application #: 017933 Labeling Supplement#: 026To Original New Drug ApplicationApproval Date: 11-FEB-02Trade Name: LENTE ILETIN I INSULINDosage Form: INJECTABLEApplicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COActive Ingredient(s): INSULIN ZINC SUSP BEEF/PORKOTC/RX Status: OTC
Application #: 017931 Labeling Supplement#: 025To Original New Drug ApplicationApproval Date: 11-FEB-02Trade Name: REGULAR ILETIN IDosage Form: INJECTABLEApplicant: ELI LILLY AND COActive Ingredient(s): INSULIN PORKOTC/RX Status: RX
Application #: 016636 Labeling Supplement#: 054To Original New Drug ApplicationApproval Date: 11-FEB-02Trade Name: NARCANDosage Form: INJECTABLEApplicant: ENDO PHARMACEUTICALS INCActive Ingredient(s): NALOXONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 016636 Labeling Supplement#: 052To Original New Drug ApplicationApproval Date: 11-FEB-02Trade Name: NARCANDosage Form: INJECTABLEApplicant: ENDO PHARMACEUTICALS INC
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Active Ingredient(s): NALOXONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 021165 Labeling Supplement #: 001To Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: CLARINEXDosage Form: TABLETApplicant: SCHERING PLOUGH CORPActive Ingredient(s): DESLORATADINEOTC/RX Status: RX
Application #: 021018 Labeling Supplement #: 001To Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: HUMALOG MIX 50/50Dosage Form: INJECTABLEApplicant: ELI LILLY AND COActive Ingredient(s): INSULIN LISPRO PROTAMINE; INSULIN LISPROOTC/RX Status: RX
Application #: 021017 Labeling Supplement #: 002To Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: HUMALOG MIX 75/25Dosage Form: INJECTABLEApplicant: ELI LILLY AND COActive Ingredient(s): INSULIN LISPRO PROTAMINE; INSULIN LISPROOTC/RX Status: RX
Application #: 020793 Labeling Supplement #: 004To Original New Drug ApplicationApproval Date: 08-FEB-02Trade Name: CAFCITDosage Form: SOLUTIONApplicant: OPR DEVELOPMENT LPActive Ingredient(s): CAFFEINE CITRATEOTC/RX Status: RX
Application #: 018731 Labeling Supplement #: 046To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: BUSPARDosage Form: TABLETApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
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Active Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
Application #: 017105 Labeling Supplement #: 062To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: TRANXENEDosage Form: TABLETApplicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVActive Ingredient(s): CLORAZEPATE DIPOTASSIUMOTC/RX Status: RX
Application #: 017105 Labeling Supplement #: 059To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: TRANXENEDosage Form: TABLETApplicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVActive Ingredient(s): CLORAZEPATE DIPOTASSIUMOTC/RX Status: RX
Application #: 016087 Labeling Supplement #: 081To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: VALIUMDosage Form: INJECTABLEApplicant: HOFFMANN LA ROCHE INCActive Ingredient(s): DIAZEPAMOTC/RX Status: RX
Application #: 016087 Labeling Supplement #: 079To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: VALIUMDosage Form: INJECTABLEApplicant: HOFFMANN LA ROCHE INCActive Ingredient(s): DIAZEPAMOTC/RX Status: RX
Application #: 013263 Labeling Supplement #: 075To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: VALIUMDosage Form: TABLETApplicant: HOFFMANN LA ROCHE INC
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Active Ingredient(s): DIAZEPAMOTC/RX Status: RX
Application #: 013263 Labeling Supplement #: 072To Original New Drug ApplicationApproval Date: 07-FEB-02Trade Name: VALIUMDosage Form: TABLETApplicant: HOFFMANN LA ROCHE INCActive Ingredient(s): DIAZEPAMOTC/RX Status: RX
Application #: 010909 Labeling Supplement #: 013To Original New Drug ApplicationApproval Date: 06-FEB-02Trade Name: MIRADONDosage Form: TABLETApplicant: SCHERING CORP SUB SCHERING PLOUGH CORPActive Ingredient(s): ANISINDIONEOTC/RX Status: RX
Application #: 021039 Labeling Supplement #: 012To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: AGENERASEDosage Form: SOLUTIONApplicant: GLAXO WELLCOME INCActive Ingredient(s): AMPRENAVIROTC/RX Status: RX
Application #: 021007 Labeling Supplement #: 013To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: AGENERASEDosage Form: CAPSULE, SOFT GELATINApplicant: GLAXO WELLCOME INCActive Ingredient(s): AMPRENAVIROTC/RX Status: RX
Application #: 020779 Labeling Supplement #: 038To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: VIRACEPTDosage Form: TABLETApplicant: AGOURON PHARMACEUTICALS INC
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Active Ingredient(s): NELFINAVIR MESYLATEOTC/RX Status: RX
Application #: 020778 Labeling Supplement #: 017To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: VIRACEPTDosage Form: POWDER, FOR SUSPENSIONApplicant: AGOURON PHARMACEUTICALS INCActive Ingredient(s): NELFINAVIR MESYLATEOTC/RX Status: RX
Application #: 020578 Labeling Supplement #: 013To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: ZOLADEXDosage Form: PELLET, IMPLANTApplicant: ASTRAZENECA UK LTDActive Ingredient(s): GOSERELIN ACETATEOTC/RX Status: RX
Application #: 020484 Labeling Supplement #: 002To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: INNOHEPDosage Form: INJECTIONApplicant: BRISTOL MYERS SQUIBB PHARMA COActive Ingredient(s): TINZAPARIN SODIUMOTC/RX Status: RX
Application #: 019726 Labeling Supplement #: 034To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: ZOLADEXDosage Form: IMPLANTApplicant: ASTRAZENECA UK LTDActive Ingredient(s): GOSERELIN ACETATEOTC/RX Status: RX
Application #: 019357 Labeling Supplement #: 014To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: ETHAMOLINDosage Form: INJECTABLEApplicant: QUESTCOR PHARMACEUTICALS INC
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Active Ingredient(s): ETHANOLAMINE OLEATEOTC/RX Status: RX
Application #: 017037 Labeling Supplement #: 146To Original New Drug ApplicationApproval Date: 05-FEB-02Trade Name: HEPARIN SODIUMDosage Form: INJECTABLEApplicant: ELKINS SINN DIV AH ROBINS CO INCActive Ingredient(s): HEPARIN SODIUMOTC/RX Status: RX
Application #: 020476 Labeling Supplement #: 002To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: MOTRINDosage Form: DROPSApplicant: MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INCActive Ingredient(s): IBUPROFENOTC/RX Status: RX
Application #: 020418 Labeling Supplement #: 003To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: MOTRINDosage Form: TABLETApplicant: MCNEIL CONSUMER HEALTHCAREActive Ingredient(s): IBUPROFENOTC/RX Status: RX
Application #: 020353 Labeling Supplement #: 008To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: NAPRELANDosage Form: TABLET, CONTROLLED RELEASEApplicant: ELAN PHARMACEUTICAL RESEARCH CORPActive Ingredient(s): NAPROXEN SODIUMOTC/RX Status: RX
Application #: 020135 Labeling Supplement #: 005To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: MOTRINDosage Form: TABLET, CHEWABLEApplicant: MCNEIL CONSUMER HEALTHCARE
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Active Ingredient(s): IBUPROFENOTC/RX Status: RX
Application #: 019842 Labeling Supplement #: 013To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: MOTRINDosage Form: SUSPENSIONApplicant: MCNEIL CONSUMER HEALTHCAREActive Ingredient(s): IBUPROFENOTC/RX Status: RX
Application #: 012003 Labeling Supplement #: 024To Original New Drug ApplicationApproval Date: 04-FEB-02Trade Name: AKINETONDosage Form: TABLETApplicant: ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVActive Ingredient(s): BIPERIDEN HYDROCHLORIDEOTC/RX Status: RX
Application #: 050649 Labeling Supplement #: 007To Original New Drug ApplicationApproval Date: 01-FEB-02Trade Name: MINOCINDosage Form: CAPSULEApplicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID COActive Ingredient(s): MINOCYCLINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 050649 Labeling Supplement #: 005To Original New Drug ApplicationApproval Date: 01-FEB-02Trade Name: MINOCINDosage Form: CAPSULEApplicant: LEDERLE LABORATORIES DIV AMERICAN CYANAMID COActive Ingredient(s): MINOCYCLINE HYDROCHLORIDEOTC/RX Status: RX
FDA Drug Approvals List February 2002
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Definitions
Approvable Original New Drug ApplicationsAn approvable letter indicates that FDA is prepared to approve the application upon the satisfaction ofconditions specified in the approvable letter. Drug products which are the subject of approvable lettersmay not be legally marketed until the firm has satisfied the identified deficiencies, as well as any otherrequirements that may be imposed by FDA, and has been notified in writing that the application has beenapproved. Further information on approvable NDAs is not subject to Freedom of Information (FOI)release until applications are approved.
Original Abbreviated and 505(b)(2) New DrugApplications with Tentative ApprovalA tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent TermRestoration Act. Such drug products that are the subjects of tentative approvals may not be legallymarketed until the market exclusivity and/or patent term of the listed reference drug product has expired.Final approval is also contingent upon conditions and information available to FDA remaining acceptable.When the application receives final approval, the product may be legally marketed. The effective approvaldate will be listed in this publication and in the " Approved Drug Products with Therapeutic EquivalenceEvaluations" list published by FDA. Additional information on these applications will become available tothe public when the applications receive final approval. Notes
Notes:FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assignreview priority on the basis of the drug's chemical type and potential benefit:
Chemical Type (CHE)
1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.
2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug).
3. New formulation: A new dosageform or new formulation of an active ingredient already on the market.
4. New combination: A drug that contains two or more compounds, the combination of which has notbeen marketed together in a product.
5. Already marketed drug product but a new manufacturer: A product that duplicates another firm'salready marketed drug product: same active ingredient, formulation, or combination.
6. Already marketed drug product, but a new use: A new use for a drug product already marketed by a
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different firm.
7. Drug already legally marketed without an approved NDA
1 - First post-1962 applications for products marketed prior to 19382 - First applications for DESI-related products first marketed between 1938 and 1962without NDAs3 - First applications for DESI-related products first marketed after 1962 without NDAs - Theindications can be the same or different from the legally marketed product
Effectiveness Supplement Code Definitions
SE1 A new indication or a significant modification of an existing indication, including removal of a majorlimitation to use, such as second line status.
SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency ofadministration.
SE3 A new route of administration.
SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.
SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantlyalter the patient population to be treated, such as addition of pediatric use and/or dosing information orgeriatric use and/or dosing information.
SE6 An Rx-to-OTC switch.
SE7 Supplement-Accelerated Approval
SE8 Efficacy Supplement with Clinical Data to Support Labeling Claim
Treatment Potential (TP)
P-Priority review drug: A drug that appears to represent an advance over available therapy
S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an alreadymarketed drug.
Other Designations (may apply simultaneously)
AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.
E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treatlifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of FederalRegulations, Part 312, Subpart E, which governs this classification. Also see, "The Evolution of U.S. Drug
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Law," page 26 of the booklet, From Test Tube to Patient: NEW DRUG
DEVELOPMENT IN THE UNITED STATES.)
V Designated orphan drug: A drug for which the sponsor received orphan designation under the OrphanDrug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.
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December 07, 200119 Mar 2002 14:41:21 -0500http://www.fda.gov/cder/da/da0202.htm
FDA Drug Approvals List February 2002
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Drug Approvals for March 2002
Definitions and Notes
Original New Drug ApplicationsOriginal Application #: 020855Approval Date: 21-MAR-02Trade Name: MESNAChemical Type: 3Therapeutic Potential: SDosage Form: TABLETApplicant: ASTA MEDICA AGActive Ingredient(s): MESNAOTC/RX Status: RXIndication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide-inducedhemorrhagic cystitis
Original Application #: 021260Approval Date: 20-MAR-02Trade Name: AVINZAChemical Type: 3Therapeutic Potential: SDosage Form: CAPSULE, EXTENDED RELEASEApplicant: ELAN PHARMACEUTICAL RESEARCH CORPActive Ingredient(s): MORPHINE SULFATEOTC/RX Status: RXIndication(s): For the relief of moderate to severe pain requiring continuous around-the-clock opioidtherapy for an extended period of time
Original Application #: 021113Approval Date: 04-MAR-02Trade Name: PAMIDRONATE DISODIUM INJECTIONChemical Type: 5Therapeutic Potential: SDosage Form: INJECTABLE
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Applicant: BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INCActive Ingredient(s): PAMIDRONATE DISODIUMOTC/RX Status: RXIndication(s): For the treatment of moderate or severe hypercalcemia associated with malignancy, with orwithout bone metastases, for the treatment of patients with moderate to severe Paget's disease of bone, andfor the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myelomain conjunction with standard antineoplastic therapy
Original Application #: 021342Approval Date: 01-MAR-02Trade Name: LEVO-TChemical Type: 5Therapeutic Potential: SDosage Form: TABLETApplicant: MOVA PHARMACEUTICALL CORPORATIONActive Ingredient(s): LEVOTHYROXINE SODIUMOTC/RX Status: RXIndication(s): For the treatment of hypothyroidism and suppression of thyroid-stimulating hormone
Efficacy Supplemental New Drug Applications
Application #: 020933 Efficacy Supplement#: 007Type: SE7 to Original New Drug ApplicationApproval Date: 27-MAR-02Trade Name: VIRAMUNEDosage Form: SOLUTIONApplicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INCActive Ingredient(s): NEVIRAPINEOTC/RX Status: RXEfficacy Claim: In combination with other antiretroviral agents for the treatment of HIV-1 infection
Application #: 020636 Efficacy Supplement#: 017Type: SE7 to Original New Drug ApplicationApproval Date: 27-MAR-02Trade Name: VIRAMUNEDosage Form: TABLETApplicant: BOEHRINGER INGELHEIM PHARMACEUTICALS INCActive Ingredient(s): NEVIRAPINEOTC/RX Status: RX
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Efficacy Claim:In combination with other antiretroviral agents for the treatment of HIV-1 infection
Application #: 020692 Efficacy Supplement#: 016Type: SE1 to Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: SEREVENTDosage Form: POWDER, FOR INHALATIONApplicant: GLAXOSMITHKLINEActive Ingredient(s): SALMETEROL XINAFOATEOTC/RX Status: RXEfficacy Claim: For the long=term, twice-daily (morning and evening) administration in the maintenancetreatment of bronchospasm associated with COPD (including emphysema and chronic bonchitis)
Application #: 020150 Efficacy Supplement#: 011Type: SE6 to Original New Drug ApplicationApproval Date: 21-MAR-02Trade Name: NICOTROLDosage Form: FILM, CONTROLLED RELEASEApplicant: PHARMACIA AND UPJOHN CONSUMER HEALTHCAREActive Ingredient(s): NICOTINEOTC/RX Status: RXEfficacy Claim: For the Over-the-Counter (OTC) marketing of Nicotrol TD step-down regimen for adults18 years of age and older, to reduce withdrawal symptoms, including nicotine craving, associated withquitting smoking
Application #: 020744 Efficacy Supplement#: 004Type: SE8 to Original New Drug ApplicationApproval Date: 01-MAR-02Trade Name: CUROSURFDosage Form: SUSPENSIONApplicant: DEY, LPActive Ingredient(s): PORACTANT ALFAOTC/RX Status: RXEfficacy Claim: For the treatment (rescue) of Respiratory Distress Syndrome (RDS) in premature infants
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Approvable Original New Drug Applications
Original Abbreviated New Drug Applications
Original Abbreviated Application # 040398Approval Date: 29-MAR-02Trade Name: MICORT-HC LIPOCREAMDosage Form: CREAMApplicant: FERNDALE LABORATORIES, INCActive Ingredient(s): HYDROCORTISONE ACETATEOTC/RX Status: RX
Original Abbreviated Application # 040412Approval Date: 29-MAR-02Trade Name: HYDROCHLOROTHIAZIDEDosage Form: TABLETApplicant: VINTAGE PHARMACEUTICALS, INCActive Ingredient(s): HYDROCHLOROTHIAZIDEOTC/RX Status: RX
Original Abbreviated Application # 076153Approval Date: 27-MAR-02Trade Name: PAMIDRONATE DISODIUMDosage Form: INJECTABLEApplicant: GENSIA SICOR PHARMACEUTICALS INCActive Ingredient(s): PAMIDRONATE DISODIUMOTC/RX Status: RX
Original Abbreviated Application # 076264Approval Date: 22-MAR-02Trade Name: NALTREXONE HCLDosage Form: TABLETApplicant: MALLINCKRODT INCActive Ingredient(s): NALTREXONE HYDROCHLORIDEOTC/RX Status: RX
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Original Abbreviated Application # 075803Approval Date: 20-MAR-02Trade Name: LEVONORGESTREL AND ETHINYL ESTRADIOLDosage Form: TABLETApplicant: BARR LABORATORIES INCActive Ingredient(s): ETHINYL ESTRADIOL;LEVONORGESTRELOTC/RX Status: RX
Original Abbreviated Application # 076200Approval Date: 19-MAR-02Trade Name: ACETAMINOPHENDosage Form: TABLET,EXTENDED RELEASEApplicant: COREPHARMA LLCActive Ingredient(s): ACETAMINOPHENOTC/RX Status: OTC
Original Abbreviated Application # 075860Approval Date: 19-MAR-02Trade Name: DESONIDEDosage Form: LOTIONApplicant: ALTANA INCActive Ingredient(s): DESONIDEOTC/RX Status: RX
Original Abbreviated Application # 075413Approval Date: 19-MAR-02Trade Name: BUSPIRONE HCLDosage Form: TABLETApplicant: GENEVA PHARMACEUTICALS INCActive Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065076Approval Date: 19-MAR-02Trade Name: AMPICILLIN SODIUM AND SULBACTAM SODIUMDosage Form: INJECTABLEApplicant: ESI LEDERLE INCActive Ingredient(s): SULBACTAM SODIUM; AMPICILLIN SODIUM
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OTC/RX Status: RX
Original Abbreviated Application # 076067Approval Date: 18-MAR-02Trade Name: MOMETASONE FUROATEDosage Form: OINTMENTApplicant: CLAY PARK LABORATORIES INCActive Ingredient(s): MOMETASONE FUROATEOTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065009Approval Date: 18-MAR-02Trade Name: ERYTHROMYCINDosage Form: GELApplicant: GLADES PHARMACEUTICALS INCActive Ingredient(s): ERYTHROMYCINOTC/RX Status: RX
Original Abbreviated Application # 040431Approval Date: 18-MAR-02Trade Name: FLUDROCORTISONE ACETATEDosage Form: TABLETApplicant: IMPAX LABORATORIES INCActive Ingredient(s): FLUDROCORTISONE ACETATEOTC/RX Status: RX
Original Abbreviated Application # 076058Approval Date: 15-MAR-02Trade Name: MIDAZOLAM HCLDosage Form: SYRUPApplicant: RANBAXY LABORATORIES LTDActive Ingredient(s): MIDAZOLAM HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Application # 075737Approval Date: 15-MAR-02Trade Name: MINOXIDIL
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Dosage Form: SOLUTIONApplicant: CLAY PARK LABORATORIES INCActive Ingredient(s): MINOXIDILOTC/RX Status: OTC
Original Abbreviated Antibiotic Application# 065064Approval Date: 15-MAR-02Trade Name: AMOXICILLIN AND CLAVULANATE POTASSIUMDosage Form: TABLETApplicant: GENEVA PHARMACEUTICALS INCActive Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUMOTC/RX Status: RX
Original Abbreviated Application # 075995Approval Date: 14-MAR-02Trade Name: IBUPROFENDosage Form: TABLETApplicant: L PERRIGO COActive Ingredient(s): IBUPROFENOTC/RX Status: OTC
Original Abbreviated Application # 075119Approval Date: 14-MAR-02Trade Name: BUSPIRONE HCLDosage Form: TABLETApplicant: EGIS PHARMACEUTICALSActive Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated Antibiotic Application# 065063Approval Date: 14-MAR-02Trade Name: AMOXICILLIN AND CLAVULANATE POTASSIUMDosage Form: TABLETApplicant: GENEVA PHARMACEUTICALS INCActive Ingredient(s): AMOXICILLIN; CLAVULANATE POTASSIUMOTC/RX Status: RX
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Original Abbreviated Application # 075824Approval Date: 12-MAR-02Trade Name: BUTORPHANOLDosage Form: SPRAY, METEREDApplicant: ROXANE LABORATORIES INCActive Ingredient(s): BUTORPHANOL TARTRATEOTC/RX Status: RX
Original Abbreviated Application # 075610Approval Date: 12-MAR-02Trade Name: FAMOTIDINEDosage Form: TABLETApplicant: TORPHARM INCActive Ingredient(s): FAMOTIDINEOTC/RX Status: OTC
Original Abbreviated Application# 075385Approval Date: 01-MAR-02Trade Name: BUSPIRONE HYDROCHLORIDEDosage Form: TABLETApplicant: ZENITH GOLDLINE PHARMACEUTICALS, INCActive Ingredient(s): BUSPIRONE HYDROCHLORIDEOTC/RX Status: RX
Original Abbreviated and 505(b)(2) New DrugApplications with Tentative Approval
Original Abbreviated Application #: 075400Tentative Approval Date: 25-MAR-02Trade Name: FAMOTIDINEDosage Form: TABLETApplicant: L PERRIGO COActive Ingredient(s): FAMOTIDINEOTC/RX Status: RX
Original Abbreviated Application #: 074732Tentative Approval Date: 21-MAR-02
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Trade Name:TAMOXIFEN CITRATEDosage Form: TABLETApplicant: MYLAN PHARMACEUTICALS INCActive Ingredient(s): TAMOXIFEN CITRATEOTC/RX Status: RX
Original Abbreviated Application #: 074539Tentative Approval Date: 21-MAR-02Trade Name:TAMOXIFEN CITRATEDosage Form: TABLETApplicant: TEVA PHARMACEUTICALSActive Ingredient(s): TAMOXIFEN CITRATEOTC/RX Status: RX
Labeling Supplements to Original New DrugApplications
Application #: 050750 Labeling Supplement#: 003To Original New Drug ApplicationApproval Date: 27-MAR-02Trade Name: ZOSYNDosage Form: INJECTABLEApplicant:WYETH-AYERST RESEARCHActive Ingredient(s): TAZOBACTAM SODIUM; PIPERACILLIN SODIUMOTC/RX Status: RX
Application #: 050684 Labeling Supplement#: 015To Original New Drug ApplicationApproval Date: 27-MAR-02Trade Name: ZOSYNDosage Form: INJECTABLEApplicant: WYETH AYERST LABORATORIESActive Ingredient(s): TAZOBACTAM SODIUM; PIPERACILLIN SODIUMOTC/RX Status: RX
Application #: 018017 Labeling Supplement#: 037To Original New Drug Application
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Approval Date: 27-MAR-02Trade Name: BLOCADRENDosage Form: TABLETApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): TIMOLOL MALEATEOTC/RX Status: RX
Application #: 050632 Labeling Supplement#: 011To Original New Drug ApplicationApproval Date: 25-MAR-02Trade Name: AZACTAMDosage Form: INJECTABLEApplicant: BRISTOL MYERS SQUIBB COActive Ingredient(s): AZTREONAMOTC/RX Status: RX
Application #: 050580 Labeling Supplement#: 033To Original New Drug ApplicationApproval Date: 25-MAR-02Trade Name: AZACTAMDosage Form: INJECTABLEApplicant: BRISTOL MYERS SQUIBBActive Ingredient(s): AZTREONAMOTC/RX Status: RX
Application #: 050634 Labeling Supplement#: 014To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: FORTAZDosage Form: INJECTABLEApplicant: GLAXOSMITHKLINEActive Ingredient(s): CEFTAZIDIME SODIUMOTC/RX Status: RX
Application #: 050578 Labeling Supplement#: 042To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: FORTAZDosage Form: INJECTABLE
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Applicant: GLAXOSMITHKLINEActive Ingredient(s): CEFTAZIDIMEOTC/RX Status: RX
Application #: 020624 Labeling Supplement#: 008To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: ANZEMETDosage Form: INJECTABLEApplicant: AVENTIS PHARMACEUTICALS INCActive Ingredient(s): DOLASETRON MESYLATE MONOHYDRATEOTC/RX Status: RX
Application #: 019779 Labeling Supplement#: 014To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: IOPIDINEDosage Form: SOLUTIONApplicant: ALCON LABORATORIES INCActive Ingredient(s): APRACLONIDINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 017874 Labeling Supplement#: 032To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: TRANSDERM SCOPDosage Form: FILM, CONTROLLED RELEASEApplicant: NOVARTIS CONSUMER HEALTH INCActive Ingredient(s): SCOPOLAMINEOTC/RX Status: RX
Application #: 017029 Labeling Supplement#: 099To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: HEPARIN SODIUMDosage Form: INJECTABLEApplicant: AMERICAN PHARMACEUTICAL PARTNERS INCActive Ingredient(s): HEPARIN SODIUMOTC/RX Status: RX
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Application #: 009053 Labeling Supplement#: 020To Original New Drug ApplicationApproval Date: 22-MAR-02Trade Name: PURINETHOLDosage Form: TABLETApplicant: GLAXOSMITHKLINEActive Ingredient(s): MERCAPTOPURINEOTC/RX Status: RX
Application #: 050753 Labeling Supplement#: 002To Original New Drug ApplicationApproval Date: 21-MAR-02Trade Name: TOBIDosage Form: SOLUTION, FOR INHALATIONApplicant: CHIRON CORPActive Ingredient(s): TOBRAMYCINOTC/RX Status: RX
Application #: 050641 Labeling Supplement#: 008To Original New Drug ApplicationApproval Date: 21-MAR-02Trade Name: MONODOXDosage Form: CAPSULEApplicant: OCLASSEN PHARMACEUTICALS INCActive Ingredient(s): DOXYCYCLINEOTC/RX Status: RX
Application #: 018201 Labeling Supplement#: 037To Original New Drug ApplicationApproval Date: 21-MAR-02Trade Name: MODURETIC 5-50Dosage Form: TABLETApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDEOTC/RX Status: RX
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Application #: 018200 Labeling Supplement#: 024To Original New Drug ApplicationApproval Date: 21-MAR-02Trade Name: MIDAMORDosage Form: TABLETApplicant: MERCK AND CO INCActive Ingredient(s): AMILORIDE HYDROCHLORIDEOTC/RX Status: RX
Application #: 018771 Labeling Supplement#: 012To Original New Drug ApplicationApproval Date: 20-MAR-02Trade Name: LACRISERTDosage Form: SUPPOSITORY, INSERTApplicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INCActive Ingredient(s): HYDROXYPROPYL CELLULOSEOTC/RX Status: RX
Application #: 017714 Labeling Supplement#: 021To Original New Drug ApplicationApproval Date: 20-MAR-02Trade Name: AN-DTPADosage Form: INJECTABLEApplicant: CIS US INCActive Ingredient(s): TECHNETIUM TC-99M PENTETATE KITOTC/RX Status: RX
Application #: 020204 Labeling Supplement#: 008To Original New Drug ApplicationApproval Date: 19-MAR-02Trade Name: ALEVEDosage Form: TABLETApplicant: BAYER CORP CONSUMER CARE DIVActive Ingredient(s): NAPROXENOTC/RX Status: OTC
Application #: 050658 Labeling Supplement#: 009To Original New Drug ApplicationApproval Date: 18-MAR-02
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Trade Name: TIMENTINDosage Form: INJECTABLEApplicant: GLAXOSMITHKLINEActive Ingredient(s): TICARCILLIN DISODIUM; CLAVULANATE POTASSIUMOTC/RX Status: RX
Application #: 050590 Labeling Supplement#: 040To Original New Drug ApplicationApproval Date: 18-MAR-02Trade Name: TIMENTINDosage Form: POWDER, FOR INJECTION SOLUTIONApplicant: GLAXOSMITHKLINEActive Ingredient(s): TICARCILLIN DISODIUM; CLAVULANATE POTASSIUMOTC/RX Status: RX
Application #: 017831 Labeling Supplement#: 052To Original New Drug ApplicationApproval Date: 15-MAR-02Trade Name: DIDRONELDosage Form: TABLETApplicant: PROCTER AND GAMBLE PHARMACEUTICALS INCActive Ingredient(s): ETIDRONATE DISODIUMOTC/RX Status: RX
Application #: 020458 Labeling Supplement #: 002To Original New Drug ApplicationApproval Date: 14-MAR-02Trade Name: GALZINDosage Form: CAPSULEApplicant: TEVA PHARMACEUTICALS USA INCActive Ingredient(s): ZINC ACETATEOTC/RX Status: RX
Application #: 018897 Labeling Supplement #: 016To Original New Drug ApplicationApproval Date: 14-MAR-02Trade Name: SODIUM CHLORIDE IN PLASTIC CONTAINERDosage Form: INJECTABLEApplicant: ABBOTT LABORATORIES HOSP PRODUCTS DIV
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Active Ingredient(s): SODIUM CHLORIDEOTC/RX Status: RX
Application #: 018892 Labeling Supplement #: 021To Original New Drug ApplicationApproval Date: 14-MAR-02Trade Name: SODIUM PHOSPHATES IN PLASTIC CONTAINERDosage Form: INJECTABLEApplicant: ABBOTT LABORATORIESActive Ingredient(s): SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS; SODIUMPHOSPHATE, DIBASIC, HEPTAHYDRATEOTC/RX Status: RX
Application #: 020747 Labeling Supplement #: 010To Original New Drug ApplicationApproval Date: 12-MAR-02Trade Name: ACTIQDosage Form: TABLETApplicant: ANESTA CORPActive Ingredient(s): FENTANYL CITRATEOTC/RX Status: RX
Application #: 019032 Labeling Supplement #: 017To Original New Drug ApplicationApproval Date: 12-MAR-02Trade Name: TENEXDosage Form: TABLETApplicant: A.H. ROBBINSActive Ingredient(s): GUANFACINE HYDROCHLORIDEOTC/RX Status: RX
Application #: 019032 Labeling Supplement #: 016To Original New Drug ApplicationApproval Date: 12-MAR-02Trade Name: TENEXDosage Form: TABLETApplicant: A.H. ROBBINSActive Ingredient(s): GUANFACINE HYDROCHLORIDEOTC/RX Status: RX
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Application #: 019991 Labeling Supplement #: 032To Original New Drug ApplicationApproval Date: 11-MAR-02Trade Name: NOVOLIN 70/30Dosage Form: INJECTABLEApplicant: NOVO NORDISK PHARMACEUTICALS INCActive Ingredient(s): INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHAN ERECOMBINANT HUMANOTC/RX Status: OTC
Application #: 019959 Labeling Supplement #: 031To Original New Drug ApplicationApproval Date: 11-MAR-02Trade Name: NOVOLIN NDosage Form: INJECTABLEApplicant: NOVO NORDISK PHARMACEUTICALS INCActive Ingredient(s): INSULIN SUSP ISOPHANE RECOMBINANT HUMANOTC/RX Status: OTC
Application #: 019938 Labeling Supplement #: 030To Original New Drug ApplicationApproval Date: 11-MAR-02Trade Name: NOVOLIN RDosage Form: INJECTABLEApplicant: NOVO NORDISK PHARMACEUTICALS INCActive Ingredient(s): INSULIN RECOMBINANT HUMANOTC/RX Status: OTC
Application #: 020903 Labeling Supplement #: 020To Original New Drug ApplicationApproval Date: 06-MAR-02Trade Name: REBETOLDosage Form: CAPSULEApplicant: SCHERING PLOUGH RESEARCH INSTITUTEActive Ingredient(s): RIBAVIRINOTC/RX Status: RX
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Application #: 020671 Labeling Supplement #: 009To Original New Drug ApplicationApproval Date: 06-MAR-02Trade Name: HYCAMTINDosage Form: INJECTABLEApplicant: GLAXOSMITHKLINEActive Ingredient(s): TOPOTECAN HYDROCHLORIDEOTC/RX Status: RX
Application #: 020075 Labeling Supplement #: 016To Original New Drug ApplicationApproval Date: 06-MAR-02Trade Name: LIORESALDosage Form: INJECTABLEApplicant: MEDTRONIC INCActive Ingredient(s): BACLOFENOTC/RX Status: RX
Application #: 020075 Labeling Supplement #: 014To Original New Drug ApplicationApproval Date: 06-MAR-02Trade Name: LIORESALDosage Form: INJECTABLEApplicant: MEDTRONIC INCActive Ingredient(s): BACLOFENOTC/RX Status: RX
Application #: 019962 Labeling Supplement #: 022To Original New Drug ApplicationApproval Date: 05-MAR-02Trade Name: TOPROL-XLDosage Form: TABLET, EXTENDED RELEASEApplicant: ASTRAZENECA LPActive Ingredient(s): METOPROLOL SUCCINATEOTC/RX Status: RX
Application #: 020262 Labeling Supplement #: 038To Original New Drug Application
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Approval Date: 04-MAR-02Trade Name: TAXOLDosage Form: INJECTABLEApplicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTEActive Ingredient(s): PACLITAXELOTC/RX Status: RX
Definitions
Approvable Original New Drug ApplicationsAn approvable letter indicates that FDA is prepared to approve the application upon the satisfaction ofconditions specified in the approvable letter. Drug products which are the subject of approvable lettersmay not be legally marketed until the firm has satisfied the identified deficiencies, as well as any otherrequirements that may be imposed by FDA, and has been notified in writing that the application has beenapproved. Further information on approvable NDAs is not subject to Freedom of Information (FOI)release until applications are approved.
Original Abbreviated and 505(b)(2) New DrugApplications with Tentative ApprovalA tentative approval indicates that FDA has given an abbreviated new drug application (ANDA) or505(b)(2) application provisional approval under the terms of the Drug Price Competition and Patent TermRestoration Act. Such drug products that are the subjects of tentative approvals may not be legallymarketed until the market exclusivity and/or patent term of the listed reference drug product has expired.Final approval is also contingent upon conditions and information available to FDA remaining acceptable.When the application receives final approval, the product may be legally marketed. The effective approvaldate will be listed in this publication and in the " Approved Drug Products with Therapeutic EquivalenceEvaluations" list published by FDA. Additional information on these applications will become available tothe public when the applications receive final approval. Notes
Notes:FDA classifies investigational new drug applications (INDs) and new drug applications (NDAs) to assignreview priority on the basis of the drug's chemical type and potential benefit:
Chemical Type (CHE)
1. New molecular entity, or NME: An active ingredient that has never been marketed in this country.
2. New derivative: A chemical derived from an active ingredient already marketed (a "parent" drug).
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3. New formulation: A new dosageform or new formulation of an active ingredient already on the market.
4. New combination: A drug that contains two or more compounds, the combination of which has notbeen marketed together in a product.
5. Already marketed drug product but a new manufacturer: A product that duplicates another firm'salready marketed drug product: same active ingredient, formulation, or combination.
6. Already marketed drug product, but a new use: A new use for a drug product already marketed by adifferent firm.
7. Drug already legally marketed without an approved NDA
1 - First post-1962 applications for products marketed prior to 19382 - First applications for DESI-related products first marketed between 1938 and 1962without NDAs3 - First applications for DESI-related products first marketed after 1962 without NDAs - Theindications can be the same or different from the legally marketed product
Effectiveness Supplement Code Definitions
SE1 A new indication or a significant modification of an existing indication, including removal of a majorlimitation to use, such as second line status.
SE2 A new dosage regimen, including an increase or decrease in daily dosage, or a change in frequency ofadministration.
SE3 A new route of administration.
SE4 A comparative efficacy claim naming another drug, including a comparative pharmacokinetic claim.
SE5 A change in sections other than the INDICATIONS AND USAGE section that would significantlyalter the patient population to be treated, such as addition of pediatric use and/or dosing information orgeriatric use and/or dosing information.
SE6 An Rx-to-OTC switch.
SE7 Supplement-Accelerated Approval
SE8 Efficacy Supplement with Clinical Data to Support Labeling Claim
Treatment Potential (TP)
P-Priority review drug: A drug that appears to represent an advance over available therapy
S-Standard review drug: A drug that appears to have therapeutic qualities similar to those of an alreadymarketed drug.
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Other Designations (may apply simultaneously)
AA AIDS drug: A drug indicated for treating AIDS or other HIV related disease.
E Subpart E drug: A drug developed or evaluated under special procedures for drugs to treatlifethreatening or severely debilitating illnesses. (The name refers to Title 21 of the Code of FederalRegulations, Part 312, Subpart E, which governs this classification. Also see, "The Evolution of U.S. Drug
Law," page 26 of the booklet, From Test Tube to Patient: NEW DRUG
DEVELOPMENT IN THE UNITED STATES.)
V Designated orphan drug: A drug for which the sponsor received orphan designation under the OrphanDrug Act. Such a sponsor is eligible for tax credits and exclusive marketing rights for the drug.
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