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Details for New Drug Application (NDA): 078790

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NDA 078790 describes DIVALPROEX SODIUM, which is a drug marketed by Zydus Pharms Usa Inc, G And W Labs Inc, Wockhardt, Mylan, Vintage, Anchen Pharms, Nu Pharm, Aurobindo Pharma Ltd, Amneal Pharms, Teva, Orchid Hlthcare, Dr Reddys Labs Ltd, Unichem Labs Ltd, Reddys, Actavis Labs Fl Inc, Upsher Smith, Lupin, Sandoz, Impax Labs, and Sun Pharm Inds, and is included in thirty NDAs. It is available from fifty-two suppliers. Additional details are available on the DIVALPROEX SODIUM profile page.

The generic ingredient in DIVALPROEX SODIUM is divalproex sodium. There are seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for NDA: 078790

Tradename:
DIVALPROEX SODIUM
Applicant:
Lupin
Ingredient:
divalproex sodium
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078790

Suppliers and Packaging for NDA: 078790

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 078790 ANDA Rebel Distributors Corp 21695-817 21695-817-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-817-60)
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 078790 ANDA Rebel Distributors Corp 21695-818 21695-818-60 60 TABLET, DELAYED RELEASE in 1 BOTTLE (21695-818-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Jul 29, 2008TE:ABRLD:No


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