Product Details for NDA 021710
EQUETRO (CARBAMAZEPINE)
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
300MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021710
Product Number: 001
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQUETRO (CARBAMAZEPINE)
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021710
Product Number: 001
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021710
Product Number: 002
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQUETRO (CARBAMAZEPINE)
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N021710
Product Number: 002
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Prescription
Active Ingredient: CARBAMAZEPINE
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021710
Product Number: 003
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: EQUETRO
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N021710
Product Number: 003
Approval Date: Dec 10, 2004
Applicant Holder Full Name: VALIDUS PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information