Application 022152
- Type
- NDA
- Sponsor
- BIONPHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STAVZOR | VALPROIC ACID | CAPSULE, DELAYED RELEASE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | STAVZOR | VALPROIC ACID | CAPSULE, DELAYED RELEASE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | STAVZOR | VALPROIC ACID | CAPSULE, DELAYED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85663 | SUPPL | 2026-04-10 |
| 85629 | SUPPL | 2026-04-02 |
| 85618 | SUPPL | 2026-04-02 |
| 69433 | SUPPL | 2021-12-01 |
| 69432 | SUPPL | 2021-12-01 |
| 69431 | SUPPL | 2021-12-01 |
| 61499 | SUPPL | 2020-01-02 |
| 61469 | SUPPL | 2019-12-30 |
| 17022 | SUPPL | 2014-09-03 |
| 6971 | SUPPL | 2014-09-03 |
| 38312 | SUPPL | 2014-03-10 |
| 6970 | SUPPL | 2014-03-10 |
| 17021 | SUPPL | 2013-06-18 |
| 6969 | SUPPL | 2013-06-18 |
| 17020 | SUPPL | 2013-03-01 |
| 17019 | SUPPL | 2013-03-01 |
| 29326 | SUPPL | 2013-02-28 |
| 6968 | SUPPL | 2013-02-28 |
| 44684 | ORIG | 2009-08-25 |
| 21946 | ORIG | 2009-08-25 |
| 38311 | SUPPL | 2009-05-12 |
| 29325 | SUPPL | 2009-05-04 |
| 29324 | SUPPL | 2009-02-06 |
| 38310 | ORIG | 2008-08-07 |
| 6967 | ORIG | 2008-07-31 |