Application 077296
- Type
- ANDA
- Sponsor
- CELLTRION
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 |
|---|---|---|---|---|---|---|---|
| A077296-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | |
| A077296-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | |
| A077296-003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077296-001 | AB |
| A077296-002 | AB |
| A077296-003 | AB |
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 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077296-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077296-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077296-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077296-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077296-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077296-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077296-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077296-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077296-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077296-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077296-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077296-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077296-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077296-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077296-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077296-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077296-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077296-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077296-001 | AB | 1 | 301d65b070ca… |
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 | A-S Medication Solutions | ea5c5e3c-c23f-4ec0-b1ab-6b317f3d2f91 | 2025-11-12 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Mylan Institutional Inc. | b367d81d-4eca-4e28-b490-34be4c003561 | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 1107f190-bef1-41cb-9393-8479b0a56040 | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 71296464-0c09-4ff2-beb3-377af77dc4cf | 2025-10-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | fbaff0ae-431e-4e83-81c2-41eb4b18ee87 | 2025-10-22 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 79e6dc26-a38b-4642-a216-1fa1213b919a | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | df8f3825-a037-4343-859d-e59bca5f1e43 | 2025-09-24 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Coupler LLC | 3eee54a6-5b4c-330d-e063-6394a90a9f18 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | d67af03a-5261-4358-8787-2e729267ff7e | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 47412563-ec3e-44fd-9f3f-c00b9b09033a | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | cd6fe37a-d26d-4ae8-a894-b44878e6bf8e | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 0822300b-68c0-4e70-b1ba-8eb42cf373f7 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | e4a815eb-ea20-482a-bb67-06ab34264515 | 2025-08-19 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Proficient Rx LP | 15ffe3d8-d483-4c45-adc4-1cc8a5b68d19 | 2025-08-01 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | American Health Packaging | ca6bbec6-5631-4436-957e-fb8707e1683d | 2025-07-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Coupler LLC | 38f4f2fd-400b-ccc4-e063-6294a90a5f41 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | ATLANTIC BIOLOGICALS CORP. | 699a9722-27bd-4e90-819b-d4ecb99466c8 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | ATLANTIC BIOLOGICALS CORP. | 57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 8b3cb30a-8d81-4aa9-bdb4-19413ae5fedf | 2025-06-11 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | American Health Packaging | 2e4778d8-8798-4da1-bb33-1aa1414b5809 | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55648-973 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-974 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-975 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 64679-973 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |
| 64679-974 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |
| 64679-975 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | Wockhardt USA LLC. | ANDA | Current |