FDA.reportPublic FDA data

Application 078445

Type
ANDA
Sponsor
ANCHEN PHARMS

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
10370-510Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
10370-510Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
10370-510Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
10370-511Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
10370-511Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
10370-511Divalproex SodiumDivalproex SodiumPar Pharmaceutical, Inc.ANDACurrent
43063-295Divalproex SodiumDivalproex SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-295Divalproex SodiumDivalproex SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-295Divalproex SodiumDivalproex SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-3913Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
67046-143Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
70518-1498Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1498Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2497Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent