Treats asthma. NDA 21077, held by Glaxo Grp Ltd. Fluticasone Propionate; Salmeterol Xinafoate.
As of Nov 14, 2026, NDA 21077 (Advair Diskus 100/50, Advair Diskus 250/50, Advair Diskus 500/50), held by Glaxo Grp Ltd, was first approved by FDA on Aug 24, 2000, with 28 approved supplements and 0 published complete response letters.
Fluticasone Propionate/Salmeterol DISKUS is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist (LABA) indicated for: Twice-daily treatment of asthma in patients aged 4 years and older. Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Important limitation of use: Not indicated for relief of acute bronchospasm. ( 1.1, 1.2 ) 1.1 Treatment of Asthma Fluticasone Propionate/Salmeterol DISKUS is indicated for the twice-daily treatment of asthma in patients aged 4 years and older.
| Dec 20, 2017 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2017 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 2009 | Supplement 36Efficacy (new indication or use) | Approved | |
| Apr 30, 2008 | Supplement 29Efficacy (new indication or use) | Approved | |
| Apr 21, 2004 | Supplement 17Efficacy (new indication or use) | Approved | |
| Nov 17, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 2000 | Original applicationNew combination · Standard review | Approved |
| Advair Diskus 100/500.1MG/INH;EQ 0.05MG BASE/INH · powder;inhalation | Fluticasone Propionate; Salmeterol Xinafoate | RxReference drug |
| Advair Diskus 250/500.25MG/INH;EQ 0.05MG BASE/INH · powder;inhalation | Fluticasone Propionate; Salmeterol Xinafoate | RxReference drug |
| Advair Diskus 500/500.5MG/INH;EQ 0.05MG BASE/INH · powder;inhalation | Fluticasone Propionate; Salmeterol Xinafoate | RxReference drug |
| Jan 7, 2019 | Supplement 61Labeling · Standard review | Approved | |
| Dec 20, 2017 | Supplement 57Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2017 | Supplement 56Efficacy (new indication or use) · Standard review | Approved | |
| Feb 28, 2017 | Supplement 58Labeling · Standard review | Approved | |
| Apr 29, 2016 | Supplement 54Labeling · Standard review | Approved | |
| Nov 13, 2014 | Supplement 53Labeling · Standard review | Approved | |
| Jun 17, 2014 | Supplement 52Manufacturing · Standard review | Approved | |
| Apr 14, 2014 | Supplement 51Labeling · Standard review | Approved | |
| Jun 19, 2013 | Supplement 50Manufacturing · Standard review | Approved | |
| Aug 9, 2012 | Supplement 49REMS | Approved | |
| Aug 9, 2012 | Supplement 48Labeling · Standard review | Approved | None posted |
| Jun 27, 2011 | Supplement 47REMS | Approved | |
| May 10, 2011 | Supplement 46REMS | Approved | |
| Jan 4, 2011 | Supplement 41REMS | Approved | |
| Jun 25, 2010 | Supplement 42Labeling | Approved | |
| Mar 31, 2009 | Supplement 36Efficacy (new indication or use) | Approved | |
| Apr 30, 2008 | Supplement 29Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Supplement 27Labeling · Standard review | Approved | |
| Sep 27, 2006 | Supplement 26Labeling · Standard review | Approved | |
| Mar 2, 2006 | Supplement 28Labeling · Standard review | Approved | |
| Sep 28, 2004 | Supplement 22Labeling · Standard review | Approved | |
| Apr 21, 2004 | Supplement 17Efficacy (new indication or use) | Approved | |
| Nov 17, 2003 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 11, 2003 | Supplement 19Labeling · Standard review | Approved | |
| Aug 21, 2002 | Supplement 8Labeling · Standard review | Approved | |
| May 17, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 16, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 22, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 24, 2000 | Original applicationNew combination · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
