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ACID | CAPSULE, DELAYED RELEASE;ORAL | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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ACID | CAPSULE, DELAYED RELEASE;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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ACID | CAPSULE, DELAYED RELEASE;ORAL | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| N022152-001 | STAVZOR | VALPROIC ACID | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | |
| N022152-002 | STAVZOR | VALPROIC ACID | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | |
| N022152-003 | STAVZOR | VALPROIC ACID | 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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UTC | 2026-02 | N022152-001 | STAVZOR | 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2008-07-29 | 011fe1cb6892… | |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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | 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 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | 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 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | 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 | 8072bd15b7f6… |
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 | American Health Packaging | 4b619f73-44e5-4a99-b425-a96cb2228c87 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| VALPROIC ACID | VALPROIC ACID | REMEDYREPACK INC. | 65c1589e-c591-4b79-b75e-884c0d609ae8 | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic | VALPROIC ACID | Actavis Pharma, Inc. | cef3e335-5891-412f-89c4-79fcd2f145b7 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Bionpharma Inc. | ceb52870-76d0-4108-a1d4-ba7096fbacdd | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Chartwell RX, LLC | 8051ad62-3b6e-461e-8090-60f5c0a904f4 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | REMEDYREPACK INC. | ec41025a-ed7d-48c8-9005-08e3a9417f30 | 2026-04-23 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Xttrium Laboratories Inc. | 3b124a29-30bd-d30e-e063-6294a90ac4ca | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | ANI Pharmaceuticals, Inc. | 2314af65-b928-42a9-91eb-6372909ab4f5 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Chartwell Governmental & Specialty RX, LLC. | 5d19f389-7180-4e01-845f-519b7ea60ba0 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| VALPROIC ACID | VALPROIC ACID | Major Pharmaceuticals | a33f7657-ad0f-43e9-ba48-024746e6d08e | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | REMEDYREPACK INC. | 1edd220d-d151-4177-9a29-9fee36489fb7 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Kesin Pharma Corporation | 3a2155d0-e79d-3e11-e063-6294a90a4aae | 2025-07-17 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| valproic acid | VALPROIC ACID | Upsher-Smith Laboratories, LLC | 7d4df6ad-3d53-4664-9200-749487bf3689 | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | ATLANTIC BIOLOGICALS CORP. | 453444b6-1f50-49de-ab3c-1e429c83bffa | 2025-06-27 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | NCS HealthCare of KY, LLC dba Vangard Labs | 8785a152-3010-4370-aaf5-11315a1a56e1 | 2025-06-04 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic | VALPROIC ACID | Aphena Pharma Solutions - Tennessee, LLC | 34a0d45a-4388-7d8b-e063-6394a90a6c3f | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| VALPROIC ACID | VALPROIC ACID | PAI Holdings, LLC dba PAI Pharma | 7d5cb52e-37dd-4dfa-a6f4-09f9548846c6 | 2025-01-24 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Bryant Ranch Prepack | a9cef1ec-ba52-4849-8889-87898d6f4199 | 2025-01-24 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| Valproic Acid | VALPROIC ACID | Direct_Rx | 8bdbacb1-b38a-3282-e053-2a95a90af022 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
| VALPROIC ACID | VALPROIC ACID | Bryant Ranch Prepack | db53c5aa-d7a5-49ba-8227-c2d67ced23e2 | 2024-10-04 | Boxed warning, Warnings, Adverse reactions | VALPROIC ACID |
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 |