Product Details for ANDA 212948
CARBAMAZEPINE (CARBAMAZEPINE)
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
400MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 001
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CARBAMAZEPINE (CARBAMAZEPINE)
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 001
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 002
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
CARBAMAZEPINE (CARBAMAZEPINE)
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 002
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
400MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 003
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: CARBAMAZEPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212948
Product Number: 003
Approval Date: Sep 30, 2021
Applicant Holder Full Name: ANBISON LABORATORY CO LTD
Marketing Status: Prescription
Patent and Exclusivity Information