Details for New Drug Application (NDA): 219772
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The generic ingredient in BRIVARACETAM is brivaracetam. Fifteen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 219772
| Tradename: | BRIVARACETAM |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | brivaracetam |
| Patents: | 0 |
Pharmacology for NDA: 219772
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 219772
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | brivaracetam | SOLUTION;ORAL | 219772 | ANDA | Ascend Laboratories, LLC | 67877-904 | 67877-904-58 | 1 BOTTLE in 1 CARTON (67877-904-58) / 300 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
| Approval Date: | Feb 23, 2026 | TE: | AA | RLD: | No | ||||
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