Application 091627
- Type
- ANDA
- Sponsor
- SAGENT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | INJECTABLE;INTRAVENOUS | 500MG/5ML (100MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091627-001 | LEVETIRACETAM | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091627-001 | AP |
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 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A091627-001 | LEVETIRACETAM | 500MG/5ML (100MG/ML) | INJECTABLE / INTRAVENOUS | AP | 2013-06-26 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A091627-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A091627-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A091627-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091627-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091627-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091627-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091627-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091627-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091627-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091627-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091627-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091627-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091627-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091627-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091627-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091627-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091627-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091627-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091627-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091627-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091627-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091627-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091627-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091627-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091627-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091627-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091627-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091627-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091627-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091627-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A091627-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A091627-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091627-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091627-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091627-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091627-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A091627-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A091627-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091627-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091627-001 | AP | 1 | f41ea6bd6efb… |
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 | REMEDYREPACK INC. | a05bbfa4-c34f-4134-8207-db79e4c70445 | 2026-06-12 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | 23073db5-3fc4-4051-a22d-e49a63e42647 | 2026-06-10 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | 94d042f7-93b9-43bd-9ace-cfc61903b4d7 | 2026-06-08 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | 74ccc9f1-b957-4b1b-9464-1b5e3318c916 | 2026-06-08 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | PD-Rx Pharmaceuticals, Inc. | c4b2da6a-ed50-4a54-90bd-32f76b178736 | 2026-06-08 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 53843871-23e3-974e-e063-6394a90a8042 | 2026-06-05 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Cardinal Health 107, LLC | f924d55d-d7ec-4448-b54e-3a7eaf5a1cab | 2026-06-04 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | REMEDYREPACK INC. | c12d8af3-39a8-4690-8d47-43dec70b7579 | 2026-06-01 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Injecta Medcial LLC | 52fa0eec-3dd9-59ca-e063-6394a90a9791 | 2026-05-29 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Preferred Pharmaceuticals, Inc. | 419b3dba-ae21-4268-ac8b-342aaa609554 | 2026-05-18 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | c4a3018a-3cd8-4e07-a840-099ceae01c91 | 2026-05-15 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 51b66893-f7d6-8f9d-e063-6294a90a8e9b | 2026-05-13 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Lupin Pharmaceuticals, Inc. | df661166-325d-4071-9bc1-f7bf992996d2 | 2026-05-11 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | ASCLEMED USA INC. | a3c57d82-511c-4c7d-84ff-f791f931f576 | 2026-05-07 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 513f422f-1637-5f41-e063-6294a90ab548 | 2026-05-07 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | 65a76fcb-31a8-4c5a-9ffe-5393fc4dac34 | 2026-05-06 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| levetiracetam | LEVETIRACETAM | Bryant Ranch Prepack | ba18ead0-69d7-453a-badc-cd6ad376d18e | 2026-05-06 | Warnings, Adverse reactions | levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM | Coupler LLC | 5037a86a-21f2-d793-e063-6394a90a2cb5 | 2026-04-24 | Warnings, Adverse reactions | Levetiracetam LEVETIRACETAM |
| Levetiracetam | LEVETIRACETAM IN SODIUM CHLORIDE | Somerset Therapeutics, LLC | 2b37c579-ebe7-4ce1-8a34-03e974a77439 | 2026-04-20 | Warnings, Adverse reactions | Levetiracetam |
| LEVETIRACETAM | LEVETIRACETAM | Bionpharma Inc. | 1d75b15e-881c-a00f-e063-6394a90a4138 | 2026-04-17 | Warnings, Adverse reactions | LEVETIRACETAM LEVETIRACETAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.