Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020931

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TIKOSYN (DOFETILIDE)
0.125MG
Marketing Status: Prescription

Active Ingredient: DOFETILIDE
Proprietary Name: TIKOSYN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020931
Product Number: 001
Approval Date: Oct 1, 1999
Applicant Holder Full Name: PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TIKOSYN (DOFETILIDE)
0.25MG
Marketing Status: Prescription

Active Ingredient: DOFETILIDE
Proprietary Name: TIKOSYN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020931
Product Number: 002
Approval Date: Oct 1, 1999
Applicant Holder Full Name: PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TIKOSYN (DOFETILIDE)
0.5MG
Marketing Status: Prescription

Active Ingredient: DOFETILIDE
Proprietary Name: TIKOSYN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020931
Product Number: 003
Approval Date: Oct 1, 1999
Applicant Holder Full Name: PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
Marketing Status:  Prescription
Patent and Exclusivity Information