Application 019794
- Type
- NDA
- Sponsor
- ABBOTT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPAKOTE CP | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG BASE | No | No |
| 002 | DEPAKOTE CP | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 500MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019794-001 | DEPAKOTE CP | DIVALPROEX SODIUM | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | ||
| N019794-002 | DEPAKOTE CP | DIVALPROEX SODIUM | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 |
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 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019794-001 | DEPAKOTE CP | EQ 250MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019794-002 | DEPAKOTE CP | EQ 500MG BASE | TABLET, DELAYED RELEASE / ORAL | 1990-07-11 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Divalproex sodium | DIVALPROEX SODIUM | Camber Pharmaceuticals, Inc. | e8e954d4-54e3-491c-867c-b3b656b70f23 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 74a9f020-f7a1-44e2-a452-f0e37bd3e077 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | St. Mary's Medical Park Pharmacy | 35a91dd3-19d0-09cb-e063-6394a90af01b | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | St. Mary's Medical Park Pharmacy | 35a95333-9fc1-7a9f-e063-6294a90a9f30 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Major Pharmaceuticals | 4a0fa934-ec8c-460e-86eb-11281728fe85 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Unichem Pharmaceuticals (USA), Inc. | 1d4129ae-0ce8-4a04-9f9d-c770508de8ed | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Unit Dose Solutions, Inc. | 547d8305-bfc5-f4da-e063-6294a90a6106 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 4fc50afb-67f3-4bf3-9ec3-cc12734f47fd | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | NorthStar Rx LLC | aab6b411-11e9-4a16-afb6-d471ba4756e9 | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 41e32cd5-1393-4ef1-81cb-8e3795e30682 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | a999f402-be1d-4153-b743-cfdb95ed1562 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 7ead614c-a68d-4a2f-94d0-e6404a8f8760 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 6af40b06-0a92-454c-9277-80e89de27231 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Coupler LLC | 533245ba-7088-c929-e063-6294a90abe1d | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 8e86a610-45ef-4be7-a3ab-f656f5b32706 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 79132bea-04d8-4dd9-bd31-07f0ba805c21 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | beba3da1-e80d-45b4-9bd6-3ed85c9482f3 | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | BluePoint Laboratories | b95494e2-ee7a-7415-e053-2995a90ae852 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Ajanta Pharma USA Inc. | 773a289b-65ed-4045-80c5-f00e28c1c079 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | NorthStar Rx LLC | 589ae3a6-8b2e-d931-d36b-1937287ab5c0 | 2026-05-20 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23555 | ORIG | 2011-12-20 |