FDA.reportPublic FDA data

Application 204134

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 12.5MG BASENoNo
002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo
003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORALEQ 37.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-645PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
68180-645PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
68180-646PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
68180-646PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
68180-647PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
68180-647PAROXETINEPAROXETINELupin Pharmaceuticals, Inc.ANDACurrent
70518-3613PAROXETINEPAROXETINEREMEDYREPACK INC.ANDACurrent