Application 078700
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG VALPROIC ACID | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078700-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A078700-001 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | e64feba35796… |
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 | REMEDYREPACK INC. | 7e96b724-5f5f-43cb-8d8b-adff3e1fc779 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | d524db34-99c4-4837-a532-a619f82c21ba | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | bbe7d9b9-70e4-4531-a24f-5918966d94f5 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 66b0a3e0-70df-469e-845f-17769482304b | 2026-08-17 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 5e59609f-d79d-414b-a6fc-7efb1ba5b200 | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | BluePoint Laboratories | 352b4c3c-e419-4827-9e00-febb0164e0f5 | 2026-08-12 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 0816a066-9ee3-4c23-944d-3539fc2c12bf | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | bb94bbb1-07c1-49be-8c2c-f5635c65366d | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | aa386ae3-ceac-4e3b-8fb1-ced3107a4c54 | 2026-08-04 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 0339e27d-3dbf-4c37-a14e-f53557c08e19 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Major Pharmaceuticals | 4ef6c5fd-42b2-4419-9b5a-e6d63571e3a0 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 5926c3ff-c995-4789-941c-d38aa7db94dc | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Aurobindo Pharma Limited | 6240cee7-6aa8-425c-ba46-f889a640f0fa | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | PD-Rx Pharmaceuticals, Inc. | 90225548-85a8-4ea7-95d3-e8231c36fe5a | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | PD-Rx Pharmaceuticals, Inc. | a67855ff-a879-43f0-bca3-94c304348bf5 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | PD-Rx Pharmaceuticals, Inc. | 392df14f-4d65-4be9-973b-1f0ce1013d8f | 2026-07-17 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 33f07aac-4dc5-4f97-976a-a84f93497bc6 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | 3b41cd15-9981-4d44-9c4b-e84168d86453 | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Dr. Reddy's Laboratories Ltd | fa823ee0-0c69-6b85-da1e-9bb2e2150ea5 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Dr. Reddy's Laboratories Ltd | 2e35f833-1cf7-12eb-9567-7a191e32e138 | 2026-07-07 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |