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Last Updated: September 23, 2020

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Details for New Drug Application (NDA): 073229

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NDA 073229 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 073229
Tradename:VALPROIC ACID
Applicant:Catalent
Ingredient:valproic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 073229
Medical Subject Heading (MeSH) Categories for 073229
Suppliers and Packaging for NDA: 073229
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid CAPSULE;ORAL 073229 ANDA Actavis Pharma, Inc. 0591-4012 0591-4012-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-4012-01)
VALPROIC ACID valproic acid CAPSULE;ORAL 073229 ANDA Upsher-Smith Laboratories, LLC 0832-0310 0832-0310-11 100 CAPSULE in 1 BOTTLE (0832-0310-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Oct 29, 1991TE:ABRLD:No

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