Product Details for NDA 202834
FYCOMPA (PERAMPANEL)
2MG
Marketing Status: Prescription
4MG
Marketing Status: Prescription
6MG
Marketing Status: Prescription
8MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
12MG
Marketing Status: Prescription
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
FYCOMPA (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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
FYCOMPA (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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
FYCOMPA (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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
FYCOMPA (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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
FYCOMPA (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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: CATALYST PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information