Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 020712

Expand all

CARBATROL (CARBAMAZEPINE)
100MG
Marketing Status: Prescription

Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBATROL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020712
Product Number: 003
Approval Date: Sep 30, 1997
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBATROL (CARBAMAZEPINE)
200MG
Marketing Status: Prescription

Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBATROL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020712
Product Number: 001
Approval Date: Sep 30, 1997
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CARBATROL (CARBAMAZEPINE)
300MG
Marketing Status: Prescription

Active Ingredient: CARBAMAZEPINE
Proprietary Name: CARBATROL
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020712
Product Number: 002
Approval Date: Sep 30, 1997
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information