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Federal Trade Commission
Fish and Richardson

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074060

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NDA 074060 describes VALPROIC ACID, which is a drug marketed by Bionpharma Inc, Catalent, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Usl Pharma, Ani Pharms Inc, Apotex Inc, Eci Pharms Llc, High Tech Pharma, Pharm Assoc, Vintage, Vistapharm, and Wockhardt Bio Ag, and is included in fourteen NDAs. It is available from twenty-three suppliers. Additional details are available on the VALPROIC ACID profile page.

The generic ingredient in VALPROIC ACID is valproic acid. There are seventeen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 074060
Applicant:High Tech Pharma
Ingredient:valproic acid
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 074060
Medical Subject Heading (MeSH) Categories for 074060
Suppliers and Packaging for NDA: 074060
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid SYRUP;ORAL 074060 ANDA Watson Laboratories, Inc. 0591-0426 E 0591-0426-16
VALPROIC ACID valproic acid SYRUP;ORAL 074060 ANDA Atlantic Biologicals Corps 17856-0792 N 17856-0792-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Jan 13, 1995TE:AARLD:No

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