Product Details for NDA 020789
ZONEGRAN (ZONISAMIDE)
25MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG
Marketing Status: Prescription
Active Ingredient: ZONISAMIDE
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020789
Product Number: 003
Approval Date: Aug 22, 2003
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZONEGRAN (ZONISAMIDE)
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020789
Product Number: 003
Approval Date: Aug 22, 2003
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: ZONISAMIDE
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020789
Product Number: 001
Approval Date: Mar 27, 2000
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
ZONEGRAN (ZONISAMIDE)
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020789
Product Number: 001
Approval Date: Mar 27, 2000
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ZONISAMIDE
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020789
Product Number: 002
Approval Date: Aug 22, 2003
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZONEGRAN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020789
Product Number: 002
Approval Date: Aug 22, 2003
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information