FDA.reportPublic FDA data

Application 204095

Type
ANDA
Sponsor
MYLAN

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4230DesvenlafaxinedesvenlafaxineMylan Pharmaceuticals IncANDACurrent
0378-4230DesvenlafaxinedesvenlafaxineMylan Pharmaceuticals Inc.ANDACurrent
0378-4231DesvenlafaxinedesvenlafaxineMylan Pharmaceuticals IncANDACurrent
0378-4231DesvenlafaxinedesvenlafaxineMylan Pharmaceuticals Inc.ANDACurrent
68151-5295DesvenlafaxinedesvenlafaxineCarilion Materials ManagementANDACurrent
71335-0798DesvenlafaxinedesvenlafaxineBryant Ranch PrepackANDACurrent
71335-0798DesvenlafaxinedesvenlafaxineBryant Ranch PrepackANDACurrent