FDA.reportPublic FDA data

Application 204020

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG BASENoNo
002DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG BASENoNo
003DESVENLAFAXINE SUCCINATEDESVENLAFAXINE SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-105DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-469DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-469DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-469DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-741DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-741DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-741DesvenlafaxineDesvenlafaxineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1311DesvenlafaxineDesvenlafaxineZydus Lifesciences LimitedANDACurrent
70771-1311DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1311DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1311DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1311DesvenlafaxineDesvenlafaxineZydus Lifesciences LimitedANDACurrent
70771-1312DesvenlafaxineDesvenlafaxineZydus Lifesciences LimitedANDACurrent
70771-1312DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1312DesvenlafaxineDesvenlafaxineZydus Lifesciences LimitedANDACurrent
70771-1312DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1312DesvenlafaxineDesvenlafaxineCadila Healthcare LimitedANDACurrent
70771-1661DesvenlafaxineDesvenlafaxineZydus Lifesciences LimitedANDACurrent