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 | Bryant Ranch Prepack | 48a6e47a-3697-492d-9086-56e4ca0151e5 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | c8d9cd69-ceca-3057-9d1c-12c44b19f767 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | BluePoint Laboratories | 1b12c694-e120-45f6-ad28-36373e2c5378 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 0fb57229-08ef-44d6-b40a-92b2f96ff795 | 2025-02-21 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | American Health Packaging | 64b509bc-f398-48ad-bdcb-9904e61d9225 | 2025-02-20 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Alembic Pharmaceuticals Limited | f34c4504-5409-406e-995b-138e5f700242 | 2025-01-06 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | NuCare Pharmaceuticals,Inc. | 0bef10ed-e4b5-95ae-e063-6294a90a86eb | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| divalproex sodium | DIVALPROEX SODIUM | Zydus Lifesciences Limited | b0f33792-dd96-40cc-a28e-acdcdca2f4b8 | 2024-11-28 | divalproex sodium DIVALPROEX SODIUM | |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | c8f72850-92d5-4f64-b9f1-657f72bfa15a | 2024-11-06 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 388fd4bc-f12f-4e55-a1e7-72aa585519fa | 2024-09-17 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | NCS HealthCare of KY, LLC dba Vangard Labs | 319bbead-bec8-4bb7-9ecb-b2e161c44b8d | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 9a9f5f24-e421-406f-ac91-d1f964245f54 | 2024-09-04 | Boxed warning, Warnings, Adverse reactions | Divalproex sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 8ecfe765-d743-4308-9cd9-4a7b1a229ea9 | 2024-04-23 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 63d61062-2700-47f4-8ab4-3bd641b81fe1 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | bf34dd25-abe3-4587-b481-df052f085429 | 2023-08-03 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 0f5bb45e-836b-48ce-9764-2d50edcb202c | 2023-05-19 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Hahnemann Laboratories, INC. | f7fec516-ec6f-6248-e053-6294a90a3342 | 2023-03-28 | Divalproex Sodium DIVALPROEX SODIUM | |
| Divalproex Sodium | DIVALPROEX SODIUM | Proficient Rx LP | abac11e6-7ce1-491c-9ac3-61f3df54c4a4 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | Divalproex Sodium DIVALPROEX SODIUM |
| Divalproex Sodium | DIVALPROEX SODIUM | Hahnemann Laboratories, INC. | e3281609-460a-4982-e053-2995a90a01c5 | 2022-07-06 | Divalproex Sodium DIVALPROEX SODIUM | |
| Divalproex sodium | DIVALPROEX SODIUM | Aphena Pharma Solutions - Tennessee, LLC | 177e34e9-f74d-42aa-8e3c-5fb4f41c2322 | 2018-12-19 | 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 |