Details for New Drug Application (NDA): 218249
NDA 218249 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, Breckenridge, Sciegen Pharms, Sunshine, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in nineteen NDAs. It is available from sixteen 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 218249
| Tradename: | BRIVARACETAM |
| Applicant: | Hainan Poly |
| Ingredient: | brivaracetam |
| Patents: | 0 |
Pharmacology for NDA: 218249
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 218249
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | brivaracetam | SOLUTION;INTRAVENOUS | 218249 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-1075 | 0121-1075-02 | 10 VIAL, GLASS in 1 CARTON (0121-1075-02) / 5 mL in 1 VIAL, GLASS (0121-1075-55) |
| BRIVARACETAM | brivaracetam | SOLUTION;INTRAVENOUS | 218249 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-420 | 14335-420-10 | 10 VIAL, GLASS in 1 CARTON (14335-420-10) / 5 mL in 1 VIAL, GLASS (14335-420-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 50MG/5ML (10MG/ML) | ||||
| Approval Date: | Feb 23, 2026 | TE: | AP | RLD: | No | ||||
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