Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 022416

Expand all

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: 
Application Number: N022416
Product Number: 001
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS 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: 
Application Number: N022416
Product Number: 002
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS 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: 
Application Number: N022416
Product Number: 003
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS 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: 
Application Number: N022416
Product Number: 004
Approval Date: Nov 8, 2013
Applicant Holder Full Name: SUNOVION PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English