FDA.reportPublic FDA data

Application 203730

Type
ANDA
Sponsor
AMNEAL 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
0904-7181Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7181Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7182Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
0904-7182Divalproex SodiumDivalproex SodiumMajor PharmaceuticalsANDACurrent
50268-259Divalproex SodiumDivalproex SodiumAvPAKANDACurrent
50268-260Divalproex SodiumDivalproex SodiumAvPAKANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-755Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
65162-757Divalproex SodiumDivalproex SodiumAmneal Pharmaceuticals LLCANDACurrent
67046-150Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
67296-1677Divalproex SodiumDivalproex SodiumRedPharm Drug, Inc.ANDACurrent
67296-1677Divalproex SodiumDivalproex SodiumRedPharm Drug, Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7295Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-1556Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2036Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-2510Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
71610-311Divalproex SodiumDivalproex SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32463ORIG2015-06-03