Details for New Drug Application (NDA): 214748
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NDA 214748 describes BRIVARACETAM, which is a drug marketed by Aurobindo Pharma Ltd, Lupin Ltd, MSN, Sunshine, and Zydus Pharms, and is included in five NDAs. It is available from five suppliers. Additional details are available on the BRIVARACETAM profile page.
The generic ingredient in BRIVARACETAM is brivaracetam. Six suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
The generic ingredient in BRIVARACETAM is brivaracetam. Six suppliers are listed for this compound. Additional details are available on the brivaracetam profile page.
Summary for 214748
| Tradename: | BRIVARACETAM |
| Applicant: | Sunshine |
| Ingredient: | brivaracetam |
| Patents: | 0 |
Pharmacology for NDA: 214748
| Mechanism of Action | Epoxide Hydrolase Inhibitors |
Suppliers and Packaging for NDA: 214748
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 214748 | ANDA | Solaris?Pharma?Corporation | 73473-904 | 73473-904-60 | 60 TABLET, FILM COATED in 1 BOTTLE (73473-904-60) |
| BRIVARACETAM | brivaracetam | TABLET;ORAL | 214748 | ANDA | Solaris?Pharma?Corporation | 73473-905 | 73473-905-60 | 60 TABLET, FILM COATED in 1 BOTTLE (73473-905-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 9, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Jun 9, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jun 9, 2022 | TE: | AB | RLD: | No | ||||
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