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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 075379

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NDA 075379 describes VALPROIC ACID, which is a drug marketed by Bionpharma Inc, Catalent, Novelgenix Theraps, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Upsher Smith Labs, Ani Pharms Inc, Apotex, Eci Pharms Llc, High Tech Pharma, Lannett Co Inc, Pharm Assoc, Vistapharm, and Wockhardt Bio Ag, and is included in fifteen NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 075379
Applicant:Pharm Assoc
Ingredient:valproic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 075379
Medical Subject Heading (MeSH) Categories for 075379
Suppliers and Packaging for NDA: 075379
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid SYRUP;ORAL 075379 ANDA Pharmaceutical Associates, Inc. 0121-0675 0121-0675-16 473 mL in 1 BOTTLE (0121-0675-16)
VALPROIC ACID valproic acid SYRUP;ORAL 075379 ANDA Pharmaceutical Associates, Inc. 0121-1350 0121-1350-00 10 TRAY in 1 CASE (0121-1350-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Dec 15, 2000TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

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