Application 077324
- Type
- ANDA
- Sponsor
- FOSUN PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
| 004 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 1GM | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077324-001 | LEVETIRACETAM | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | ||
| A077324-002 | LEVETIRACETAM | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | ||
| A077324-003 | LEVETIRACETAM | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | ||
| A077324-004 | LEVETIRACETAM | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 |
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 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077324-001 | LEVETIRACETAM | 250MG | TABLET / ORAL | 2009-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077324-002 | LEVETIRACETAM | 500MG | TABLET / ORAL | 2009-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077324-003 | LEVETIRACETAM | 750MG | TABLET / ORAL | 2009-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077324-004 | LEVETIRACETAM | 1GM | TABLET / ORAL | 2009-01-15 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Levetiracetam | LEVETIRACETAM | Cardinal Health 107, LLC | 0348fec4-d919-4307-ac90-35360819bc00 | 2026-09-04 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | 2d307850-0ed5-4f32-ac62-0e1e2fe27a7a | 2026-09-03 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam ER | LEVETIRACETAM | REMEDYREPACK INC. | 2d57f22f-fecc-466e-a444-87708c7c2f80 | 2026-08-27 | Warnings, Adverse reactions | LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Direct_Rx | 5517b148-1eff-6421-e063-6394a90a9498 | 2026-08-27 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| LEVETIRACETAM | LEVETIRACETAM | REMEDYREPACK INC. | 9bdef24b-c50e-4e6a-8650-59d78009f472 | 2026-08-26 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |
| LEVETIRACETAM | LEVETIRACETAM | REMEDYREPACK INC. | 17969eda-4c85-40a0-9a94-7e4675adf910 | 2026-08-21 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Ascend Laboratories, LLC | 591dd9f1-3681-4b2f-b096-7536826e3648 | 2026-08-19 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Cardinal Health 107, LLC | e1b14939-7262-40dc-a334-2b3b72c88d47 | 2026-08-10 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | a1b28234-1f7c-40bf-80a7-6cc98b3839fe | 2026-08-05 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| LEVETIRACETAM | LEVETIRACETAM | Micro Labs Limited | 1e3cfafe-5784-4ec6-91dc-cd74b01d0bb4 | 2026-08-03 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |
| Levetiracetam Levetiracetam | LEVETIRACETAM | Atlantic Biologicals Corp. | 56fed03f-38c3-4273-8fd7-522bc508bf36 | 2026-07-27 | Warnings, Adverse reactions | LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Cardinal Health 107, LLC | a91defd2-486b-4995-ba4c-640525ab575d | 2026-07-21 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | dfc218c5-672a-420a-b59e-2e0b054e99ad | 2026-07-14 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | ae405796-1eca-4890-bcb2-e1b07654a24d | 2026-07-08 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| LEVETIRACETAM | LEVETIRACETAM | Bryant Ranch Prepack | ace53552-d616-45e8-9f99-2f0041d0b430 | 2026-07-06 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 266d4ead-fda2-f030-e063-6394a90a68e2 | 2026-07-06 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | 1c26c0ad-9d37-45c5-9091-849509f4fc01 | 2026-07-02 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | 90e01877-abcb-4697-a7ed-9afe5ee77050 | 2026-06-29 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Unit Dose Solutions, Inc. | 551626eb-3282-e439-e063-6294a90a8314 | 2026-06-25 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| LEVETIRACETAM | LEVETIRACETAM | Bryant Ranch Prepack | bb6e1c75-66eb-4d18-af70-9b51fb67c4d6 | 2026-06-24 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |