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

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