Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 077636

Expand all

ZONISAMIDE (ZONISAMIDE)
25MG
Marketing Status: Prescription

Active Ingredient: ZONISAMIDE
Proprietary Name: ZONISAMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077636
Product Number: 003
Approval Date: Jul 27, 2006
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ZONISAMIDE (ZONISAMIDE)
50MG
Marketing Status: Prescription

Active Ingredient: ZONISAMIDE
Proprietary Name: ZONISAMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077636
Product Number: 002
Approval Date: Jul 27, 2006
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ZONISAMIDE (ZONISAMIDE)
100MG
Marketing Status: Prescription

Active Ingredient: ZONISAMIDE
Proprietary Name: ZONISAMIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077636
Product Number: 001
Approval Date: Dec 22, 2005
Applicant Holder Full Name: GRANULES INDIA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information