Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022416

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APTIOM (ESLICARBAZEPINE ACETATE)
200MG
Marketing Status: Prescription

Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: APTIOM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022416
Product Number: 001
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

APTIOM (ESLICARBAZEPINE ACETATE)
400MG
Marketing Status: Prescription

Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: APTIOM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022416
Product Number: 002
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

APTIOM (ESLICARBAZEPINE ACETATE)
600MG
Marketing Status: Prescription

Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: APTIOM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022416
Product Number: 003
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

APTIOM (ESLICARBAZEPINE ACETATE)
800MG
Marketing Status: Prescription

Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: APTIOM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022416
Product Number: 004
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUMITOMO PHARMA AMERICA INC
Marketing Status:  Prescription
Patent and Exclusivity Information