FDA.reportPublic FDA data

Application 209286

Type
ANDA
Sponsor
LUPIN LTD

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
0615-8376Divalproex sodiumDivalproex sodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8377Divalproex sodiumDivalproex sodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
17856-0262Divalproex sodiumDivalproex sodiumATLANTIC BIOLOGICALS CORP.ANDACurrent
50090-5783Divalproex sodiumDivalproex sodiumA-S Medication SolutionsANDACurrent
68180-260Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-260Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-260Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-261Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-261Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-261Divalproex sodiumDivalproex sodiumLupin Pharmaceuticals, Inc.ANDACurrent
68788-8085Divalproex sodiumDivalproex sodiumPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3183Divalproex sodiumDivalproex sodiumREMEDYREPACK INC.ANDACurrent
70518-3183Divalproex sodiumDivalproex sodiumREMEDYREPACK INC.ANDACurrent
70518-3477Divalproex sodiumDivalproex sodiumREMEDYREPACK INC.ANDACurrent
70518-3477Divalproex sodiumDivalproex sodiumREMEDYREPACK INC.ANDACurrent
71335-1883Divalproex sodiumDivalproex sodiumBryant Ranch PrepackANDACurrent
71335-1883Divalproex sodiumDivalproex sodiumBryant Ranch PrepackANDACurrent
72789-286Divalproex sodiumDivalproex sodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent