FDA.reportPublic FDA data

Application 078182

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0615-7531Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7532Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7533Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8326Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8326Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8327Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8327Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8328Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8328Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8328Divalproex SodiumDivalproex SodiumNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0832-7122Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7122Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7122Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7122Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7122Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7123Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7123Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7123Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7123Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7123Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7124Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7124Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7124Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7124Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
0832-7124Divalproex SodiumDivalproex SodiumUpsher-Smith Laboratories, LLCANDACurrent
50090-3416Divalproex SodiumDivalproex SodiumA-S Medication SolutionsANDACurrent
53808-1027Divalproex SodiumDivalproex SodiumState of Florida DOH Central PharmacyANDACurrent
55154-5633Divalproex SodiumDivalproex SodiumCardinal HealthANDACurrent
55154-5633Divalproex SodiumDivalproex SodiumCardinal Health 107, LLCANDACurrent
67046-120Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
67046-121Divalproex SodiumDivalproex SodiumContract Pharmacy Services-PAANDACurrent
70518-3364Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
70518-3459Divalproex SodiumDivalproex SodiumREMEDYREPACK INC.ANDACurrent
71610-031Divalproex SodiumDivalproex SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-032Divalproex SodiumDivalproex SodiumAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31341ORIG2008-08-05