FDA.reportPublic FDA data

Application 204172

Type
ANDA
Sponsor
LUPIN LTD

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
61919-882DESVENLAFAXINE ERDESVENLAFAXINE ERDirect_RxANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-592Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-593Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-604Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68180-604Desvenlafaxine SuccinateDesvenlafaxine SuccinateLupin Pharmaceuticals, Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7448Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7488Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7488Desvenlafaxine SuccinateDesvenlafaxine SuccinatePreferred Pharmaceuticals Inc.ANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1150Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent
71335-1331Desvenlafaxine SuccinateDesvenlafaxine SuccinateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10305ORIG2015-07-08