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Valproate sodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for valproate sodium?

Valproate sodium is the generic ingredient in two branded drugs marketed by Hikma Farmaceutica, Fresenius Kabi Usa, Abbvie, and Amphastar Pharms Inc, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for valproate sodium. Three suppliers are listed for this compound.

Summary for Generic Name: valproate sodium

Drug Master File Entries: see list9
Suppliers / Packagers: see list3
Bulk Api Vendors: see list131
Clinical Trials: see list958
Patent Applications: see list5,011
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:valproate sodium at DailyMed

Pharmacology for Ingredient: valproate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
valproate sodium
INJECTABLE;INJECTION076539-001Jun 26, 2003RXNoNo► Subscribe► Subscribe
Hikma Farmaceutica
valproate sodium
INJECTABLE;INJECTION078523-001Feb 17, 2010RXNoNo► Subscribe► Subscribe
valproate sodium
INJECTABLE;INJECTION020593-001Dec 30, 1996RXYesYes► Subscribe► Subscribe
Amphastar Pharms Inc
valproate sodium
INJECTABLE;INJECTION076295-001Nov 14, 2002RXNoNo► Subscribe► Subscribe
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