Details for New Drug Application (NDA): 209801
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NDA 209801 describes PERAMPANEL, which is a drug marketed by MSN and Teva Pharms Usa Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PERAMPANEL profile page.
The generic ingredient in PERAMPANEL is perampanel. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the perampanel profile page.
The generic ingredient in PERAMPANEL is perampanel. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 209801
| Tradename: | PERAMPANEL |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | perampanel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209801
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERAMPANEL | perampanel | TABLET;ORAL | 209801 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7062 | 0480-7062-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-7062-56) |
| PERAMPANEL | perampanel | TABLET;ORAL | 209801 | ANDA | Teva Pharmaceuticals, Inc. | 0480-7063 | 0480-7063-56 | 30 TABLET, FILM COATED in 1 BOTTLE (0480-7063-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | May 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | May 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 6MG | ||||
| Approval Date: | May 23, 2025 | TE: | AB | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Nov 25, 2025 | ||||||||
| Regulatory Exclusivity Use: | PATENT CHALLENGE | ||||||||
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