Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220470
Company: CENTAUR PHARMS PVT
Company: CENTAUR PHARMS PVT
| 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 |
|---|---|---|---|---|---|---|---|
| 02/23/2026 | ORIG-1 | Approval | STANDARD |
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 |