Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021710

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EQUETRO (CARBAMAZEPINE)
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)
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)
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