Details for New Drug Application (NDA): 219952
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The generic ingredient in BRIVARACETAM is brivaracetam. Sixteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 219952
| Tradename: | BRIVARACETAM |
| Applicant: | Sciegen Pharms |
| Ingredient: | brivaracetam |
| Patents: | 0 |
Pharmacology for NDA: 219952
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 219952
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 219952 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-556 | 50228-556-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (50228-556-10) |
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 219952 | ANDA | ScieGen Pharmaceuticals, Inc. | 50228-556 | 50228-556-30 | 30 TABLET, FILM COATED in 1 BOTTLE (50228-556-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 1, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jul 1, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jul 1, 2026 | TE: | AB | RLD: | No | ||||
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