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 | Rising Pharma Holdings, Inc. | 6316061c-9758-4f38-9cb2-7ca833dd20bf | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Lupin Pharmaceuticals, Inc. | 33798a7c-c5a9-49a5-be5d-1312910ef468 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Lupin Pharmaceuticals, Inc. | 1f081c74-9f73-4ed9-9157-8d73d586a409 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | cf15569c-5010-4e9b-aef0-7df4de5ed04e | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | ab8616a5-ea72-4df7-b095-54ea19ef6fba | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | ed24bb3a-bba1-4b27-8733-96619793fc15 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Bionpharma Inc. | 19064624-81d1-4ce3-bfe4-955bad6af6a2 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | First Nation Group, LLC | a76f9909-28c9-4eb7-8ffd-ff6222fea079 | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 283af6d2-8ea2-4225-b2e7-a2057dbdb793 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Sun Pharmaceutical Industries, Inc. | 64797788-fdcb-4d12-a1a4-743ad71bd17b | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Unichem Pharmaceuticals (USA), Inc. | 1ec1a441-218a-4c80-a0cb-69bcc327f472 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals Inc. | dc9e4871-fb3d-4c59-81e5-2ab6e8be9b7c | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Lifestar Pharma LLC | b2388bfd-7455-48ae-b396-463df0c278f0 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Dr. Reddy's Laboratories Ltd | f911748c-fb3a-fe1a-ab2a-4b40455e05ef | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Alembic Pharmaceuticals Inc. | fea19b14-d8ed-4954-bc54-b9240f78b3c3 | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals, Inc. | 83a77f60-ed58-4fa0-a584-e6a0c767d19d | 2026-04-08 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals Inc. | d1d4d790-73d5-4a3b-a786-99f2c9812546 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Zydus Pharmaceuticals USA Inc. | ed710c62-8ba6-4f19-b240-3ee73cd03d67 | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Aurobindo Pharma Limited | dbd47222-14f1-4588-a009-9b81b55ca60d | 2026-04-06 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Amneal Pharmaceuticals LLC | 7d3352ee-a240-43ff-a243-29ad2bc989c7 | 2026-04-04 | 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 |