Details for New Drug Application (NDA): 209538
✉ Email this page to a colleague
NDA 209538 describes PERAMPANEL, which is a drug marketed by MSN, Taro, and Teva Pharms Usa Inc, and is included in four NDAs. It is available from three suppliers. 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the perampanel profile page.
Summary for 209538
| Tradename: | PERAMPANEL |
| Applicant: | Taro |
| Ingredient: | perampanel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209538
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERAMPANEL | perampanel | TABLET;ORAL | 209538 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4204 | 51672-4204-3 | 2 BLISTER PACK in 1 CARTON (51672-4204-3) / 20 TABLET, FILM COATED in 1 BLISTER PACK |
| PERAMPANEL | perampanel | TABLET;ORAL | 209538 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4204 | 51672-4204-6 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51672-4204-6) |
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 | ||||
Complete Access Available with Subscription
