FDA.reportPublic FDA data

Application 091298

Type
ANDA
Sponsor
TORRENT PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 15MG BASENoNo
002PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 30MG BASENoNo
003PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDETABLET;ORALEQ 45MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13668-119PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDETorrent Pharmaceuticals LimitedANDACurrent
13668-120PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDETorrent Pharmaceuticals LimitedANDACurrent
13668-140PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDETorrent Pharmaceuticals LimitedANDACurrent
53002-1755PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-1756PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
53002-1757PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDERPK Pharmaceuticals, Inc.ANDACurrent
63187-746PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDEProficient Rx LPANDACurrent
63187-746PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDEProficient Rx LPANDACurrent
63187-746PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDEProficient Rx LPANDACurrent
68071-4822PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4822PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4889PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4889PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDENuCare Pharmaceuticals,Inc.ANDACurrent
70518-1816PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDEREMEDYREPACK INC.ANDACurrent
70518-2059PIOGLITAZONEHYDROCHLORIDEPIOGLITAZONEHYDROCHLORIDEREMEDYREPACK INC.ANDACurrent