Application 076941
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 125MG VALPROIC ACID | No | No |
| 002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 250MG VALPROIC ACID | No | No |
| 003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | TABLET, DELAYED 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 |
|---|---|---|---|---|---|---|---|
| A076941-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | ||
| A076941-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | ||
| A076941-003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076941-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076941-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076941-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | 2008-07-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A076941-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076941-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076941-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076941-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076941-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076941-003 | AB | 1 | ea99ee380514… |
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 | BluePoint Laboratories | 352b4c3c-e419-4827-9e00-febb0164e0f5 | 2026-08-12 | 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 |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 55f1614b-aadc-34ca-e063-6394a90ae2a7 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| 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 | DIVALPROEX SODIUM | REMEDYREPACK INC. | 74a9f020-f7a1-44e2-a452-f0e37bd3e077 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium 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 | 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 | DIVALPROEX SODIUM | Major Pharmaceuticals | 4a0fa934-ec8c-460e-86eb-11281728fe85 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-7439 | Divalproex Sodium | Divalproex Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7440 | Divalproex Sodium | Divalproex Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7441 | Divalproex Sodium | Divalproex Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |