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 |
|---|---|---|---|---|---|---|
| Depakote ER | DIVALPROEX SODIUM | AbbVie Inc. | 0dc024ce-efc8-4690-7cb5-639c728fccac | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Depakote | DIVALPROEX SODIUM | AbbVie Inc. | 08a65cf4-7749-4ceb-6895-8f4805e2b01f | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Depakote Sprinkles | DIVALPROEX SODIUM | AbbVie Inc. | 4619aff4-0f80-444f-858d-42e4137aa809 | 2026-03-31 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 3df910c5-b6f0-4a65-9640-b702ecea49f9 | 2026-03-23 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 94eac383-a89f-4128-b81c-076640b8edcf | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| DIVALPROEX SODIUM | DIVALPROEX SODIUM | DirectRx | ce12c7b1-caa9-4224-bb5f-3e20e0281d66 | 2026-03-17 | Warnings | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | c971b50d-0f78-422f-abee-1c5b4e1d20e7 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Safecor Health, LLC | 3aec1944-86a1-490c-a734-d9dd3b52c9d6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals Inc. | dbd1d178-77a3-46ff-985d-307dffaed1ad | 2026-02-17 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 4834732f-6044-946c-e063-6394a90a5da3 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | American Health Packaging | b12b76a0-4b6e-4cd4-9508-10a2c84d8beb | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | AvPAK | e8cc336b-5191-7f8b-e053-2a95a90a6acb | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | A-S Medication Solutions | e5fcf5b1-263e-43e0-9424-e613d5cca3fa | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Northwind Health Company, LLC | ab6fa448-7485-6644-e053-2a95a90aa181 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 46b2e8a9-5d50-d0b2-e063-6294a90a1b47 | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 0669ac77-10df-48af-bc42-55e768b69e4f | 2025-12-19 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | American Health Packaging | a8ba3986-1ded-44a8-8d10-d0f252a07794 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Upsher-Smith Laboratories, LLC | 02304a23-4a5f-47bc-9687-4044b43f7a20 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Major Pharmaceuticals | fb39a94e-93e6-4afe-a300-f80e8f1e0fa6 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | f936b9d0-a58f-4fa5-8db9-752dabb837a6 | 2025-11-14 | 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 |