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Details for New Drug Application (NDA): 208277
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The generic ingredient in FYCOMPA is perampanel. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the perampanel profile page.
Summary for 208277
Tradename: | FYCOMPA |
Applicant: | Eisai Inc |
Ingredient: | perampanel |
Patents: | 2 |
Generic Entry Opportunity Date for 208277
Generic Entry Date for 208277*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 208277
Mechanism of Action | AMPA Receptor Antagonists |
Suppliers and Packaging for NDA: 208277
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FYCOMPA | perampanel | SUSPENSION;ORAL | 208277 | NDA | Eisai Inc. | 62856-290 | 62856-290-38 | 340 mL in 1 BOTTLE (62856-290-38) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 0.5MG/ML | ||||
Approval Date: | Apr 29, 2016 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Jun 8, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | Start Trial | Patent Expiration: | Jul 1, 2026 | Product Flag? | Substance Flag? | Y | Delist Request? |
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