Details for New Drug Application (NDA): 219052
NDA 219052 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 219052
| Tradename: | PERAMPANEL |
| Applicant: | Taro |
| Ingredient: | perampanel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219052
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PERAMPANEL | perampanel | SUSPENSION;ORAL | 219052 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4256 | 51672-4256-9 | 1 BOTTLE in 1 CARTON (51672-4256-9) / 340 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 0.5MG/ML | ||||
| Approval Date: | Jun 15, 2026 | TE: | AB | RLD: | No | ||||
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