FDA.reportPublic FDA data

Application 079163

Type
ANDA
Sponsor
UNICHEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 125MG VALPROIC ACIDNoNo
002DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 250MG VALPROIC ACIDNoNo
003DIVALPROEX SODIUMDIVALPROEX SODIUMTABLET, DELAYED RELEASE;ORALEQ 500MG VALPROIC ACIDNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7949Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7949Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7950Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7950Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7956Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7956Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (ANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-138Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-139Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-140Divalproex SodiumDivalproex SodiumUnichem Pharmaceuticals (USA), Inc.ANDACurrent
45865-573Divalproex SodiumDivalproex SodiumMedsource PharmaceuticalsANDACurrent
50090-2007Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-2007Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-2007Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-2007Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-3872Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-4409Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-4861Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-4861Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
50090-4861Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
51655-365Divalproex SodiumDivalproex SodiumNorthwind PharmaceuticalsANDACurrent
51655-365Divalproex SodiumDivalproex SodiumNorthwind PharmaceuticalsANDACurrent
53808-0940Divalproex SodiumDivalproex SodiumState of Florida DOH Central PharmacyANDACurrent
53808-1080Divalproex SodiumDivalproex SodiumState of Florida DOH Central PharmacyANDACurrent
55700-938Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
55700-938Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
55700-938Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
55700-939Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
55700-939Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
55700-939Divalproex SodiumDivalproex SodiumQuality Care Products, LLCANDACurrent
58118-0040Divalproex SodiumDivalproex SodiumClinical Solutions Wholesale, LLCANDACurrent
58118-0040Divalproex SodiumDivalproex SodiumClinical Solutions Wholesale, LLCANDACurrent
58118-0040Divalproex SodiumDivalproex SodiumClinical Solutions Wholesale, LLCANDACurrent
61919-249DIVALPROEX SODIUMdivalproex sodiumDirectRxANDACurrent
61919-249DIVALPROEX SODIUMDIVALPROEX SODIUMDirectRXANDACurrent
61919-809DIVALPROEX SODIUMDIVALPROEX SODIUMDIRECT RXANDACurrent
63187-742Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-742Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-742Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-742Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-743Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-743Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-743Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63187-743Divalproex SodiumDivalproex SodiumProficient Rx LPANDACurrent
63629-4278Divalproex SodiumDivalproex SodiumBryant Ranch PrepackANDACurrent
63629-4278Divalproex SodiumDivalproex SodiumBryant Ranch PrepackANDACurrent
63629-4278Divalproex SodiumDivalproex SodiumBryant Ranch PrepackANDACurrent
67046-147Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
68001-472Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-472Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-472Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-473Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-473Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-473Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-474Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-474Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68001-474Divalproex SodiumDivalproex SodiumBluePoint LaboratoriesANDACurrent
68071-4102Divalproex SodiumDivalproex SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4102Divalproex SodiumDivalproex SodiumNuCare Pharmaceuticals,Inc.ANDACurrent
68151-4162Divalproex SodiumDivalproex SodiumCarilion Materials ManagementANDACurrent
68788-7183Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7183Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7183Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7183Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-7183Divalproex SodiumDivalproex SodiumPreferred Pharmaceuticals Inc.ANDACurrent
70518-0282Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent