FDA.reportPublic FDA data

Application 212645

Type
ANDA
Sponsor
CADILA PHARMS 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
71209-094ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-094ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-094ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-095ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-095ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-095ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-096ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-096ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
71209-096ParoxetineParoxetineCadila Pharmaceuticals LimitedANDACurrent
72241-029ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-029ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-029ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-030ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-030ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-030ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-031ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-031ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent
72241-031ParoxetineParoxetineModavar Pharmaceuticals LLCANDACurrent