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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211199

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ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE)
200MG
Marketing Status: Prescription
Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: ESLICARBAZEPINE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211199
Product Number: 001
Approval Date: Oct 6, 2023
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE)
400MG
Marketing Status: Prescription
Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: ESLICARBAZEPINE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211199
Product Number: 002
Approval Date: Oct 6, 2023
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE)
600MG
Marketing Status: Prescription
Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: ESLICARBAZEPINE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211199
Product Number: 003
Approval Date: Oct 6, 2023
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ESLICARBAZEPINE ACETATE (ESLICARBAZEPINE ACETATE)
800MG
Marketing Status: Prescription
Active Ingredient: ESLICARBAZEPINE ACETATE
Proprietary Name: ESLICARBAZEPINE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 800MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A211199
Product Number: 004
Approval Date: Oct 6, 2023
Applicant Holder Full Name: ALKEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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