Application 214918
- Type
- ANDA
- Sponsor
- LUPIN LTD
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 |
|---|---|---|---|---|---|---|---|
| A214918-001 | BRIVARACETAM | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | ||
| A214918-002 | BRIVARACETAM | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | ||
| A214918-003 | BRIVARACETAM | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | ||
| A214918-004 | BRIVARACETAM | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | ||
| A214918-005 | BRIVARACETAM | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 |
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 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214918-001 | BRIVARACETAM | 10MG | TABLET / ORAL | 2022-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214918-002 | BRIVARACETAM | 25MG | TABLET / ORAL | 2022-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214918-003 | BRIVARACETAM | 50MG | TABLET / ORAL | 2022-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214918-004 | BRIVARACETAM | 75MG | TABLET / ORAL | 2022-12-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214918-005 | BRIVARACETAM | 100MG | TABLET / ORAL | 2022-12-20 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A214918-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214918-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214918-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214918-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A214918-005 | AB | 1 | 3bdfa0b2c4d7… |
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 |
|---|---|---|---|---|---|---|
| Briviact | BRIVARACETAM | UCB, Inc. | 3cf2f439-0e97-443e-8e33-25ecef616f6c | 2026-08-20 | Warnings, Adverse reactions | BRIVARACETAM |
| brivaracetam | BRIVARACETAM | Novadoz Pharmaceuticals LLC | 11ca0e1d-1c0d-4357-9ebd-ee1e87185dde | 2026-08-14 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| BRIVARACETAM | BRIVARACETAM | Aurobindo Pharma Limited | 57cfb2c3-395d-0892-e063-6294a90a1064 | 2026-08-04 | Warnings, Adverse reactions | BRIVARACETAM BRIVARACETAM |
| brivaracetam | BRIVARACETAM | SolarisPharmaCorporation | 49f726ec-e51b-7516-e063-6294a90ae684 | 2026-08-03 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| BRIVARACETAM | BRIVARACETAM | Exelan Pharmaceuticals, Inc | bf372f42-cfc9-4fcf-8226-3936ba8833d7 | 2026-07-29 | Warnings, Adverse reactions | BRIVARACETAM BRIVARACETAM |
| brivaracetam | BRIVARACETAM | ScieGen Pharmaceuticals, Inc. | bdbb6756-654c-46f1-a85c-7d5d1a89685a | 2026-07-23 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | Aurobindo Pharma Limited | 59817617-956e-4685-81d4-7abe42f4de86 | 2026-07-14 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | Aurobindo Pharma Limited | 41e218af-048b-4e24-91d2-0b9b262d480c | 2026-07-14 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| brivaracetam | BRIVARACETAM | AvKARE | 5115c5b4-7a23-89f2-e063-6294a90a222a | 2026-03-12 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| BRIVARACETAM | BRIVARACETAM | Lupin Pharmaceuticals, Inc. | 260468dd-a604-488a-a47b-b6d82edcca37 | 2026-02-28 | Warnings, Adverse reactions | BRIVARACETAM BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | Apotex Corp. | 1915620d-4f37-56c2-437e-8362bb462d07 | 2026-02-25 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| BRIVARACETAM | BRIVARACETAM | Micro Labs Limited | c054a1c9-2aa7-473b-a04b-622596f36c95 | 2026-02-24 | Warnings, Adverse reactions | BRIVARACETAM BRIVARACETAM |
| Brivaracetam Oral Solution | BRIVARACETAM | Ascend Laboratories, LLC | c4ee9b82-1067-4efc-b3d9-f24eb0c461d5 | 2026-02-24 | Warnings, Adverse reactions | BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | Novadoz Pharmaceuticals LLC | 2c6af271-3222-4602-98a6-14754f0a29ba | 2026-02-23 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | Hainan Poly Pharm. Co., Ltd. | 3ea51292-fe03-46f5-9d9b-36986f5b7224 | 2026-02-23 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| brivaracetam | BRIVARACETAM | Zhejiang Poly Pharm. Co., Ltd. | aef3ee92-e2a6-4135-94b2-b893f893d5f2 | 2026-02-23 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| Brivaracetam | BRIVARACETAM INJECTION | PAI Holdings, LLC dba PAI Pharma | 5bc0f4c0-8b31-4622-849f-d902be93788b | 2026-02-23 | Warnings, Adverse reactions | Brivaracetam |
| brivaracetam | BRIVARACETAM | Novadoz Pharmaceuticals LLC | dca92c5b-78a8-4ee1-9f06-18320ae2a2e8 | 2026-02-19 | Warnings, Adverse reactions | brivaracetam BRIVARACETAM |
| Brivaracetam | BRIVARACETAM | PAI Holdings, LLC dba PAI Pharma | 57627ea9-3b14-4428-ad95-6ea25ecaef31 | 2026-02-03 | Warnings, Adverse reactions | Brivaracetam BRIVARACETAM |
| brivaracetam | BRIVARACETAM | Zydus Lifesciences Limited | 67c4db20-ba4d-4640-9e9c-6949b85429e3 | 2026-01-27 | brivaracetam BRIVARACETAM |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68527 | ORIG | 2021-09-02 |