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Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090210

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NDA 090210 describes DIVALPROEX SODIUM, which is a drug marketed by Zydus Pharms Usa Inc, G And W Labs Inc, Wockhardt, Mylan, Prinston Inc, 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 Labs, Lupin, Sandoz, Impax Labs, and Sun Pharm Inds, and is included in thirty NDAs. It is available from forty-nine 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-two suppliers are listed for this compound. Additional details are available on the divalproex sodium profile page.

Summary for NDA: 090210

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

Pharmacology for NDA: 090210

Suppliers and Packaging for NDA: 090210

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 090210 ANDA Aidarex Pharmaceuticals LLC 33261-621 33261-621-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-621-60)
DIVALPROEX SODIUM
divalproex sodium
TABLET, DELAYED RELEASE;ORAL 090210 ANDA State of Florida DOH Central Pharmacy 53808-0681 53808-0681-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0681-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 125MG VALPROIC ACID
Approval Date:Nov 30, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 250MG VALPROIC ACID
Approval Date:Nov 30, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrengthEQ 500MG VALPROIC ACID
Approval Date:Nov 30, 2009TE:ABRLD:No


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