FDA.reportPublic FDA data

Application 078790

Type
ANDA
Sponsor
LUPIN

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
21695-817Divalproex SodiumDivalproex SodiumRebel Distributors CorpANDACurrent
21695-818Divalproex SodiumDivalproex SodiumRebel Distributors CorpANDACurrent
21695-819Divalproex SodiumDivalproex SodiumRebel Distributors CorpANDACurrent
53808-0357Divalproex Sodiumdivalproex sodiumState of Florida DOH Central PharmacyANDACurrent
53808-0358Divalproex Sodiumdivalproex sodiumState of Florida DOH Central PharmacyANDACurrent
68180-265Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, InANDACurrent
68180-265Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-265Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-265Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-265Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-266Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, InANDACurrent
68180-266Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-266Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-266Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-266Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-267Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, InANDACurrent
68180-267Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-267Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-267Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent
68180-267Divalproex SodiumDivalproex SodiumLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9186ORIG2008-08-05