FDA.reportPublic FDA data

Application 204082

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0400DesvenlafaxineDesvenlafaxineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0400DesvenlafaxineDesvenlafaxineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0400DesvenlafaxineDesvenlafaxineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0400DesvenlafaxineDesvenlafaxineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0603DesvenlafaxineDesvenlafaxineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0603DesvenlafaxineDesvenlafaxineHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0603DesvenlafaxineDesvenlafaxineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0603DesvenlafaxineDesvenlafaxineWest-Ward Pharmaceuticals Corp.ANDACurrent
50090-4806DesvenlafaxineDesvenlafaxineA-S Medication SolutionsANDACurrent
50090-4806DesvenlafaxineDesvenlafaxineA-S Medication SolutionsANDACurrent
60687-607DesvenlafaxineDesvenlafaxineAmerican Health PackagingANDACurrent
60687-607DesvenlafaxineDesvenlafaxineAmerican Health PackagingANDACurrent
63629-7524DesvenlafaxineDesvenlafaxineBryant Ranch PrepackANDACurrent
63629-7524DesvenlafaxineDesvenlafaxineBryant Ranch PrepackANDACurrent
63629-7524DesvenlafaxineDesvenlafaxineBryant Ranch PrepackANDACurrent
70518-2244DesvenlafaxineDesvenlafaxineREMEDYREPACK INC.ANDACurrent
71335-1700DesvenlafaxineDesvenlafaxineBryant Ranch PrepackANDACurrent
71335-1700DesvenlafaxineDesvenlafaxineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32505ORIG2016-02-18