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ACID | CAPSULE, DELAYED RELEASE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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ACID | CAPSULE, DELAYED RELEASE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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ACID | CAPSULE, DELAYED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N022152-001 | STAVZOR | VALPROIC ACID | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | |
| N022152-002 | STAVZOR | VALPROIC ACID | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | |
| N022152-003 | STAVZOR | VALPROIC ACID | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022152-002 | STAVZOR | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N022152-003 | STAVZOR | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 301d65b070ca… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| VALPROIC ACID | VALPROIC ACID | QUAGEN PHARMACEUTICALS LLC | 531c0fc7-5e80-49a5-a9d1-0916ec45d52c | 2024-05-02 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Aphena Pharma Solutions - Tennessee, LLC | 3798f957-8b32-4ac0-8fd1-80283414c255 | 2017-10-17 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| valproic acid | VALPROIC ACID | Aphena Pharma Solutions - Tennessee, LLC | 3904177b-8a26-4356-9080-d2a2e3f468af | 2017-10-17 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |