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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 075782


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NDA 075782 describes VALPROIC ACID, which is a drug marketed by Bionpharma, Catalent, Eywa, Par Pharm, Scherer Rp, Sun Pharm Inds Ltd, Upsher Smith Labs, Ani Pharms, Chartwell Rx, Hikma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Pharmobedient Cnsltg, and Quagen, and is included in fifteen NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the valproic acid profile page.
Summary for 075782
Tradename:VALPROIC ACID
Applicant:Chartwell Rx
Ingredient:valproic acid
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075782
Medical Subject Heading (MeSH) Categories for 075782
Suppliers and Packaging for NDA: 075782
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALPROIC ACID valproic acid SYRUP;ORAL 075782 ANDA Chartwell RX, LLC 62135-196 62135-196-47 473 mL in 1 BOTTLE (62135-196-47)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength250MG/5ML
Approval Date:Dec 22, 2000TE:AARLD:No

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