Application 078597
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
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 |
|---|---|---|---|---|---|---|---|
| A078597-001 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | |
| A078597-002 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | |
| A078597-003 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078597-001 | AB |
| A078597-002 | AB |
| A078597-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-002 | DIVALPROEX SODIUM | EQ 250MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-003 | DIVALPROEX SODIUM | EQ 500MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078597-001 | DIVALPROEX SODIUM | EQ 125MG VALPROIC ACID | TABLET, DELAYED RELEASE / ORAL | AB | 2008-07-29 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078597-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078597-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078597-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078597-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078597-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078597-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078597-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078597-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078597-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078597-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078597-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078597-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078597-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078597-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078597-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078597-001 | AB | 1 | 1e350fbaab3a… |
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. | bb94bbb1-07c1-49be-8c2c-f5635c65366d | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 70518-3431 |
| Divalproex Sodium | DIVALPROEX SODIUM | PD-Rx Pharmaceuticals, Inc. | 90225548-85a8-4ea7-95d3-e8231c36fe5a | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | PD-Rx Pharmaceuticals, Inc. | a67855ff-a879-43f0-bca3-94c304348bf5 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | St. Mary's Medical Park Pharmacy | 35a95333-9fc1-7a9f-e063-6294a90a9f30 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | 79132bea-04d8-4dd9-bd31-07f0ba805c21 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | cf15569c-5010-4e9b-aef0-7df4de5ed04e | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 70518-1558 |
| Divalproex Sodium | DIVALPROEX SODIUM | REMEDYREPACK INC. | ed24bb3a-bba1-4b27-8733-96619793fc15 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 70518-2674 |
| Divalproex Sodium | DIVALPROEX SODIUM | Sun Pharmaceutical Industries, Inc. | 64797788-fdcb-4d12-a1a4-743ad71bd17b | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 62756-796 62756-798 62756-797 |
| Divalproex Sodium | DIVALPROEX SODIUM | Preferred Pharmaceuticals Inc. | d1d4d790-73d5-4a3b-a786-99f2c9812546 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | Cardinal Health 107, LLC | 5e59609f-d79d-414b-a6fc-7efb1ba5b200 | 2025-12-05 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 55154-2336 55154-4154 |
| Divalproex Sodium | DIVALPROEX SODIUM | Major Pharmaceuticals | fb39a94e-93e6-4afe-a300-f80e8f1e0fa6 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 0904-6860 0904-6861 |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 47412563-ec3e-44fd-9f3f-c00b9b09033a | 2025-08-26 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | cd6fe37a-d26d-4ae8-a894-b44878e6bf8e | 2025-08-25 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium D/R | DIVALPROEX SODIUM D/R | Direct_Rx | 3aff8f08-d8e8-cd13-e063-6394a90aa00c | 2025-07-28 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | Coupler LLC | 38f4f2fd-400b-ccc4-e063-6294a90a5f41 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | ATLANTIC BIOLOGICALS CORP. | 57b71a0b-c2bf-4326-9c26-0f2fe56bf5bc | 2025-06-24 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 17856-0797 |
| Divalproex Sodium | DIVALPROEX SODIUM | Bryant Ranch Prepack | 48a6e47a-3697-492d-9086-56e4ca0151e5 | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | NuCare Pharmaceuticals,Inc. | 0bef10ed-e4b5-95ae-e063-6294a90a86eb | 2025-01-03 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
| Divalproex Sodium | DIVALPROEX SODIUM | A-S Medication Solutions | c8f72850-92d5-4f64-b9f1-657f72bfa15a | 2024-11-06 | Boxed warning, Warnings, Adverse reactions | 078597 ANDA078597 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6860 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6860 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6860 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6861 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6861 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 0904-6861 | Divalproex Sodium | Divalproex Sodium | Major Pharmaceuticals | ANDA | Current |
| 17856-0797 | Divalproex Sodium | Divalproex Sodium | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 17856-0798 | Divalproex Sodium | Divalproex Sodium | ATLANTIC BIOLOGICALS CORP. | ANDA | Current |
| 33261-641 | Divalproex Sodium | Divalproex Sodium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55154-2336 | Divalproex Sodium | Divalproex Sodium | Cardinal Health | ANDA | Current |
| 55154-2336 | Divalproex Sodium | Divalproex Sodium | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4154 | Divalproex Sodium | Divalproex Sodium | Cardinal Health 107, LLC | ANDA | Current |
| 61919-648 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | DIRECT RX | ANDA | Current |
| 61919-648 | DIVALPROEX SODIUM | DIVALPROEX SODIUM | DIRECT RX | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-796 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-797 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-798 | Divalproex Sodium | Divalproex Sodium | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 64725-0797 | Divalproex Sodium | Divalproex Sodium | TYA Pharmaceuticals | ANDA | Current |
| 64725-0798 | Divalproex Sodium | Divalproex Sodium | TYA Pharmaceuticals | ANDA | Current |
| 67046-105 | Divalproex Sodium | Divalproex Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-145 | Divalproex Sodium | Divalproex Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 68001-554 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-555 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68001-556 | Divalproex Sodium | Divalproex Sodium | BluePoint Laboratories | ANDA | Current |
| 68151-1164 | Divalproex Sodium | Divalproex Sodium | Carilion Materials Management | ANDA | Current |
| 70518-0374 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0374 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0374 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0374 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0374 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-0463 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-1558 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2513 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2513 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2513 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2513 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2513 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2665 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2665 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2665 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2665 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2665 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2674 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2674 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2674 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2674 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-2674 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3431 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
| 70518-3431 | Divalproex Sodium | Divalproex Sodium | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9171 | ORIG | 2008-08-05 |