Product Details for ANDA 076311
TOPIRAMATE (TOPIRAMATE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 001
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPIRAMATE (TOPIRAMATE)
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 001
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 002
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPIRAMATE (TOPIRAMATE)
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 002
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 003
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPIRAMATE (TOPIRAMATE)
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 003
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 004
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: TOPIRAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076311
Product Number: 004
Approval Date: Mar 27, 2009
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status: Prescription
Patent and Exclusivity Information