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Generated: May 27, 2017

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Details for New Drug Application (NDA): 070868

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NDA 070868 describes VALPROIC ACID, which is a drug marketed by Apotex Inc, Eci Pharms Llc, Catalent, Par Pharm, Usl Pharma, Sun Pharm Inds Ltd, High Tech Pharma, Vintage, Wockhardt, Ani Pharms Inc, Pharm Assoc, Vistapharm, Bionpharma Inc, and Scherer Rp, and is included in fourteen NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

Summary for NDA: 070868

Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 070868

Suppliers and Packaging for NDA: 070868

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
valproic acid
SYRUP;ORAL 070868 ANDA Cardinal Health 55154-1575 55154-1575-5 5 CUP, UNIT-DOSE in 1 BAG (55154-1575-5) > 5 mL in 1 CUP, UNIT-DOSE
valproic acid
SYRUP;ORAL 070868 ANDA Morton Grove Pharmaceuticals, Inc. 60432-621 60432-621-16 473 mL in 1 BOTTLE, PLASTIC (60432-621-16)

Summary for product number 001

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

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