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 |
|---|---|---|---|---|---|---|
| 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 | 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 | DIVALPROEX SODIUM | DirectRx | ce12c7b1-caa9-4224-bb5f-3e20e0281d66 | 2026-03-17 | Warnings | DIVALPROEX SODIUM 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 | DIVALPROEX SODIUM | Safecor Health, LLC | 3aec1944-86a1-490c-a734-d9dd3b52c9d6 | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium 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 | DIVALPROEX SODIUM | Coupler LLC | 4834732f-6044-946c-e063-6394a90a5da3 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | divalproex sodium 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 | DIVALPROEX SODIUM | AvPAK | e8cc336b-5191-7f8b-e053-2a95a90a6acb | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium 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 | 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 | DIVALPROEX SODIUM | Coupler LLC | 46b2e8a9-5d50-d0b2-e063-6294a90a1b47 | 2025-12-24 | Boxed warning, Warnings, Adverse reactions | divalproex sodium 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 | DIVALPROEX SODIUM | American Health Packaging | a8ba3986-1ded-44a8-8d10-d0f252a07794 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium 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 | DIVALPROEX SODIUM | Major Pharmaceuticals | fb39a94e-93e6-4afe-a300-f80e8f1e0fa6 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium 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 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 |