Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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. | Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision | Advair Diskus (fluticasone propionate and salmeterol inhalation powder), GlaxoSmithKline, Labeling Revision | Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision | Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Approval | Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder, GlaxoSmithKline, Labeling Revision | Advair Diskus (fluticasone propionate and salmeterol inhalation powder), GlaxoSmithKline, Labeling Revision | Serevent Diskus (salmeterol xinafoate inhalation powder), GlaxoSmithKline, Labeling Revision | Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol, GlaxoSmithKline, Labeling Revision | Serevent (salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, Labeling Revision | Advair Diskus 100/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen | Advair Diskus 250/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen | Advair Diskus 500/50 (fluticasone propionate and salmeterol xinafoate) Inhalation Powder, GlaxoSmithKline, New Dosage Regimen ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com