Details for New Drug Application (NDA): 218152
NDA 218152 describes PERAMPANEL, which is a drug marketed by MSN, Taro, Aurobindo Pharma Ltd, and Teva Pharms Usa Inc, and is included in six NDAs. It is available from four suppliers. Additional details are available on the PERAMPANEL profile page.
The generic ingredient in PERAMPANEL is perampanel. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the perampanel profile page.
The generic ingredient in PERAMPANEL is perampanel. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 218152
| Tradename: | PERAMPANEL |
| Applicant: | Msn |
| Ingredient: | perampanel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218152
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERAMPANEL | perampanel | SUSPENSION;ORAL | 218152 | ANDA | Novadoz Pharmaceuticals LLC | 72205-071 | 72205-071-79 | 340 mL in 1 BOTTLE (72205-071-79) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 0.5MG/ML | ||||
| Approval Date: | Jul 11, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Jun 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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