FDA.reportPublic FDA data

Application 078791

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 250MG VALPROIC ACIDNoNo
002DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, EXTENDED RELEASE;ORALEQ 500MG VALPROIC ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-6911Divalproex SodiumDIVALPROEX SODIUMImpax GenericsANDACurrent
0115-6911Divalproex SodiumDIVALPROEX SODIUMImpax GenericsANDACurrent
0115-6922Divalproex SodiumDIVALPROEX SODIUMImpax GenericsANDACurrent
0115-6922Divalproex SodiumDIVALPROEX SODIUMImpax GenericsANDACurrent
67296-1635Divalproex SodiumDIVALPROEX SODIUMRedPharm Drug, Inc.ANDACurrent
67296-1635Divalproex SodiumDIVALPROEX SODIUMRedPharm Drug, Inc.ANDACurrent
71610-201Divalproex SodiumDIVALPROEX SODIUMAphena Pharma Solutions - Tennessee, LLCANDACurrent