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Generated: November 24, 2017

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Details for New Drug Application (NDA): 074060

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NDA 074060 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-four 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-five suppliers are listed for this compound. Additional details are available on the valproic acid profile page.

Summary for 074060

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Pharmacology for NDA: 074060

Medical Subject Heading (MeSH) Categories for 074060

Suppliers and Packaging for NDA: 074060

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID
valproic acid
SYRUP;ORAL 074060 ANDA Watson Laboratories, Inc. 0591-0426 0591-0426-16 473 mL in 1 BOTTLE, PLASTIC (0591-0426-16)
VALPROIC ACID
valproic acid
SYRUP;ORAL 074060 ANDA Atlantic Biologicals Corps 17856-0792 17856-0792-1 10 mL in 1 CUP (17856-0792-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Jan 13, 1995TE:AARLD:No


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Baxter

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