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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070868

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NDA 070868 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 070868
Tradename:VALPROIC ACID
Applicant:Wockhardt Bio Ag
Ingredient:valproic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070868
Medical Subject Heading (MeSH) Categories for 070868
Suppliers and Packaging for NDA: 070868
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid SYRUP;ORAL 070868 ANDA Morton Grove Pharmaceuticals, Inc. 60432-621 60432-621-16 473 mL in 1 BOTTLE, PLASTIC (60432-621-16)
VALPROIC ACID valproic acid SYRUP;ORAL 070868 ANDA American Health Packaging 60687-262 60687-262-56 10 TRAY in 1 CASE (60687-262-56) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-262-48) > 10 mL in 1 CUP, UNIT-DOSE (60687-262-42)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Jul 1, 1986TE:AARLD:No

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