Details for New Drug Application (NDA): 073229
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NDA 073229 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.
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 073229
| Tradename: | VALPROIC ACID |
| Applicant: | Catalent |
| Ingredient: | valproic acid |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 073229
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
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: | RX | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Oct 29, 1991 | TE: | AB | RLD: | No | ||||
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