Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214748
Company: SUNSHINE
Company: SUNSHINE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | AB | No | No |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | AB | No | No |
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/09/2022 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214748Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/30/2026 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2026 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
BRIVARACETAM
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | No | AB | 214875 | APOTEX |
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | No | AB | 220470 | CENTAUR PHARMS PVT |
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | No | AB | 214921 | MSN |
| BRIVARACETAM | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | No | AB | 214748 | SUNSHINE |
| BRIVIACT | BRIVARACETAM | 10MG | TABLET;ORAL | Prescription | Yes | AB | 205836 | UCB INC |
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | No | AB | 214875 | APOTEX |
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | No | AB | 220470 | CENTAUR PHARMS PVT |
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | No | AB | 214921 | MSN |
| BRIVARACETAM | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | No | AB | 214748 | SUNSHINE |
| BRIVIACT | BRIVARACETAM | 25MG | TABLET;ORAL | Prescription | Yes | AB | 205836 | UCB INC |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | No | AB | 214875 | APOTEX |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | No | AB | 214848 | AUROBINDO PHARMA LTD |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | No | AB | 220470 | CENTAUR PHARMS PVT |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | No | AB | 214921 | MSN |
| BRIVARACETAM | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | No | AB | 214748 | SUNSHINE |
| BRIVIACT | BRIVARACETAM | 50MG | TABLET;ORAL | Prescription | Yes | AB | 205836 | UCB INC |
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | No | AB | 214875 | APOTEX |
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | No | AB | 220470 | CENTAUR PHARMS PVT |
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | No | AB | 214921 | MSN |
| BRIVARACETAM | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | No | AB | 214748 | SUNSHINE |
| BRIVIACT | BRIVARACETAM | 75MG | TABLET;ORAL | Prescription | Yes | AB | 205836 | UCB INC |
TABLET;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | No | AB | 214875 | APOTEX |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | No | AB | 214848 | AUROBINDO PHARMA LTD |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | No | AB | 220470 | CENTAUR PHARMS PVT |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | No | AB | 214921 | MSN |
| BRIVARACETAM | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | No | AB | 214748 | SUNSHINE |
| BRIVIACT | BRIVARACETAM | 100MG | TABLET;ORAL | Prescription | Yes | AB | 205836 | UCB INC |