Details for New Drug Application (NDA): 218178
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The generic ingredient in PERAMPANEL is perampanel. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 218178
| Tradename: | PERAMPANEL |
| Applicant: | Msn |
| Ingredient: | perampanel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218178
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERAMPANEL | perampanel | TABLET;ORAL | 218178 | ANDA | Novadoz Pharmaceuticals LLC | 72205-221 | 72205-221-30 | 30 TABLET, FILM COATED in 1 BOTTLE (72205-221-30) |
| PERAMPANEL | perampanel | TABLET;ORAL | 218178 | ANDA | Novadoz Pharmaceuticals LLC | 72205-221 | 72205-221-90 | 90 TABLET, FILM COATED in 1 BOTTLE (72205-221-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Nov 25, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Nov 25, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | Nov 25, 2025 | TE: | AB | RLD: | No | ||||
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