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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090554

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NDA 090554 describes DIVALPROEX SODIUM, which is a drug marketed by Dr Reddys Labs Ltd, Mylan, Zydus Pharms Usa Inc, Actavis Labs Fl Inc, Anchen Pharms, Aurobindo Pharma Ltd, Lupin, Nu Pharm, Orchid Hlthcare, Prinston Inc, Sandoz, Sun Pharm Inds, Teva, Unichem Labs Ltd, Upsher-smith Labs, Wockhardt, Amneal Pharms, G And W Labs Inc, Impax Labs, and Reddys, and is included in thirty NDAs. It is available from forty-eight 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-one suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for 090554

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Anticonvulsants
Antimigraine Agents
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090554

Suppliers and Packaging for NDA: 090554

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554 ANDA State of Florida DOH Central Pharmacy 53808-1065 53808-1065-1 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-1065-1)
DIVALPROEX SODIUM divalproex sodium TABLET, DELAYED RELEASE;ORAL 090554 ANDA Cardinal Health 55154-4679 55154-4679-0 10 BLISTER PACK in 1 BAG (55154-4679-0) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Apr 21, 2011TE:ABRLD:No


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