Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202834

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FYCOMPA (PERAMPANEL)
2MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202834
Product Number: 001
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FYCOMPA (PERAMPANEL)
4MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202834
Product Number: 002
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FYCOMPA (PERAMPANEL)
6MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202834
Product Number: 003
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FYCOMPA (PERAMPANEL)
8MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202834
Product Number: 004
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FYCOMPA (PERAMPANEL)
10MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202834
Product Number: 005
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FYCOMPA (PERAMPANEL)
12MG Marketing Status: Prescription

Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202834
Product Number: 006
Approval Date: Oct 22, 2012
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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