Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Tikosyn (dofetilide) Capsules, Pfizer NDA 20-931 10/4/99 10/4/99 8/16/01 4/4/02 Tikosyn Indication: (1) Maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation/atrial blutter [AF/AFl]) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. (2)For the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.   For the latest approval information, locate this drug using this index.