Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212839

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XCOPRI (CENOBAMATE)
12.5MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212839
Product Number: 001
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XCOPRI (CENOBAMATE)
25MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212839
Product Number: 002
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XCOPRI (CENOBAMATE)
50MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212839
Product Number: 003
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XCOPRI (CENOBAMATE)
100MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212839
Product Number: 004
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XCOPRI (CENOBAMATE)
150MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212839
Product Number: 005
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XCOPRI (CENOBAMATE)
200MG
Marketing Status: Prescription

Active Ingredient: CENOBAMATE
Proprietary Name: XCOPRI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212839
Product Number: 006
Approval Date: Mar 10, 2020
Applicant Holder Full Name: SK LIFE SCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information