Details for New Drug Application (NDA): 022152
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NDA 022152 describes STAVZOR, which is a drug marketed by Bionpharma and is included in one NDA. Additional details are available on the STAVZOR profile page.
The generic ingredient in STAVZOR 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 STAVZOR 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 022152
| Tradename: | STAVZOR |
| Applicant: | Bionpharma |
| Ingredient: | valproic acid |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 022152
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 29, 2008 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 29, 2008 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 29, 2008 | TE: | RLD: | Yes | |||||
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