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Generated: February 18, 2019

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Details for New Drug Application (NDA): 077960

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NDA 077960 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, Lannett Co Inc, Pharm Assoc, Vistapharm, and Wockhardt Bio Ag, and is included in fourteen NDAs. It is available from twenty-two 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-three suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 077960
Applicant:Lannett Co Inc
Ingredient:valproic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 077960
Medical Subject Heading (MeSH) Categories for 077960
Suppliers and Packaging for NDA: 077960
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid SYRUP;ORAL 077960 ANDA Par Pharmaceutical 0603-1841 0603-1841-58 473 mL in 1 BOTTLE (0603-1841-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Oct 13, 2006TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Federal Trade Commission
Fish and Richardson
Chinese Patent Office
Express Scripts

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