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… Serevent (Salmeterol Xinafoate) Inhalation Aerosol, GlaxoSmithKline NDA 20-236/S28 8/11/03 8/15/03 8/15/03 Serevent (Salmeterol Xinafoate) Glaxo Wellcome 020236 12/24/98 8/7/03 Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline NDA 20-692/S-024 8/11/03 8/15/03 8/15/03 Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline NDA 20-692/S-016 3/22/02 4/8/02 3/25/02 Serevent Diskus (salmeterol xinafoate inhalation powder) Glaxo Wellcome NDA 20-692/S-001 S-002 9/25/98 9/28/98 9/28/98 5/17/01 Servent Indications: Supplement S-001 is indicated for the use of Serevent Diskus for the treatment of exercise-induced bronchospasm in patients 4 years of age and older. Supplement S-002 is indicated for the use of Serevent Diskus for the maintenance treatment of asthma and prevention of bronchospasm.   For the latest approval information, locate this drug using this index.