Product Details for NDA 020505
TOPAMAX (TOPIRAMATE)
25MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
100MG
Marketing Status: Prescription
200MG
Marketing Status: Prescription
300MG
Marketing Status: Discontinued
400MG
Marketing Status: Discontinued
25MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 004
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPAMAX (TOPIRAMATE)
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 004
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 005
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPAMAX (TOPIRAMATE)
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 005
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
100MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020505
Product Number: 001
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPAMAX (TOPIRAMATE)
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020505
Product Number: 001
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
200MG
Marketing Status: Prescription
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 002
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
TOPAMAX (TOPIRAMATE)
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020505
Product Number: 002
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
300MG
Marketing Status: Discontinued
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020505
Product Number: 003
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
TOPAMAX (TOPIRAMATE)
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020505
Product Number: 003
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
400MG
Marketing Status: Discontinued
Active Ingredient: TOPIRAMATE
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020505
Product Number: 006
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: TOPAMAX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N020505
Product Number: 006
Approval Date: Dec 24, 1996
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information