Details for New Drug Application (NDA): 075379
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NDA 075379 describes VALPROIC ACID, which is a drug marketed by Bionpharma, Catalent, Hibrow Hlthcare, 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 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.
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 075379
| Tradename: | VALPROIC ACID |
| Applicant: | Pharm Assoc |
| Ingredient: | valproic acid |
| Patents: | 0 |
Pharmacology for NDA: 075379
| Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Medical Subject Heading (MeSH) Categories for 075379
Suppliers and Packaging for NDA: 075379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VALPROIC ACID | valproic acid | SYRUP;ORAL | 075379 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-0675 | 0121-0675-85 | 473 mL in 1 BOTTLE (0121-0675-85) |
| VALPROIC ACID | valproic acid | SYRUP;ORAL | 075379 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1350 | 0121-1350-00 | 10 TRAY in 1 CASE (0121-1350-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1350-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Dec 15, 2000 | TE: | AA | RLD: | No | ||||
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