Details for New Drug Application (NDA): 214848
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NDA 214848 describes BRIVARACETAM, which is a drug marketed by Hainan Poly, Micro Labs, MSN, Shandong, Alkem Labs Ltd, Aurobindo Pharma, Lupin, Regcon Holdings, Zhejiang Poly Pharm, Apotex, Aurobindo Pharma Ltd, Centaur Pharms Pvt, Sciegen Pharms, Sunshine, and Zydus Pharms, and is included in eighteen NDAs. It is available from fifteen suppliers. Additional details are available on the BRIVARACETAM profile page.
The generic ingredient in BRIVARACETAM is brivaracetam. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
The generic ingredient in BRIVARACETAM is brivaracetam. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 214848
| Tradename: | BRIVARACETAM |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | brivaracetam |
| Patents: | 0 |
Pharmacology for NDA: 214848
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 214848
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 214848 | ANDA | Aurobindo Pharma Limited | 84386-068 | 84386-068-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-068-60) |
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 214848 | ANDA | Aurobindo Pharma Limited | 84386-069 | 84386-069-60 | 60 TABLET, FILM COATED in 1 BOTTLE (84386-069-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 6, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jan 6, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 13, 2026 | TE: | AB | RLD: | No | ||||
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