FDA.reportPublic FDA data

Application 213485

Type
ANDA
Sponsor
CONJUPRO

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
69367-335ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent
69367-335ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent
69367-336ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent
69367-336ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent
69367-337ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent
69367-337ParoxetineParoxetineWestminster Pharmaceuticals, LLCANDACurrent