Application 214501
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIVARACETAM | BRIVARACETAM | TABLET;ORAL | 10MG | No | No |
| 002 | BRIVARACETAM | BRIVARACETAM | TABLET;ORAL | 25MG | No | No |
| 003 | BRIVARACETAM | BRIVARACETAM | TABLET;ORAL | 50MG | No | No |
| 004 | BRIVARACETAM | BRIVARACETAM | TABLET;ORAL | 75MG | No | No |
| 005 | BRIVARACETAM | BRIVARACETAM | TABLET;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A214501-001 | BRIVARACETAM | BRIVARACETAM | 10MG | TABLET / ORAL | AB | 2022-10-03 | |
| A214501-002 | BRIVARACETAM | BRIVARACETAM | 25MG | TABLET / ORAL | AB | 2022-10-03 | |
| A214501-003 | BRIVARACETAM | BRIVARACETAM | 50MG | TABLET / ORAL | AB | 2022-10-03 | |
| A214501-004 | BRIVARACETAM | BRIVARACETAM | 75MG | TABLET / ORAL | AB | 2022-10-03 | |
| A214501-005 | BRIVARACETAM | BRIVARACETAM | 100MG | TABLET / ORAL | AB | 2022-10-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214501-001 | AB |
| A214501-002 | AB |
| A214501-003 | AB |
| A214501-004 | AB |
| A214501-005 | 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 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | AB | 2022-10-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | AB | 2022-10-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | AB | 2022-10-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | AB | 2022-10-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | AB | 2022-10-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | AB | 2022-10-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | AB | 2022-10-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | AB | 2022-10-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | AB | 2022-10-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | AB | 2022-10-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214501-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-10-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214501-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-10-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214501-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-10-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214501-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-10-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214501-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-10-03 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A214501-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214501-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214501-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214501-004 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A214501-005 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A214501-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214501-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214501-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214501-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214501-005 | AB | 1 | caaa826d4ba7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214501-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214501-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214501-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214501-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A214501-005 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A214501-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A214501-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A214501-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A214501-004 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A214501-005 | AB | 1 | f41ea6bd6efb… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214501-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214501-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214501-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214501-004 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A214501-005 | AB | 1 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| brivaracetam | BRIVARACETAM | Zydus Lifesciences Limited | 67c4db20-ba4d-4640-9e9c-6949b85429e3 | 2026-01-27 | 214501 ANDA214501 | |
| brivaracetam | BRIVARACETAM | Zydus Pharmaceuticals USA Inc. | d54ca946-2ddf-4a67-87c9-20a814bfd2dc | 2026-01-27 | Warnings, Adverse reactions | 214501 ANDA214501 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68082 | ORIG | 2021-07-14 |