NDA 20549, held by Glaxosmithkline. Fluticasone Propionate.
As of Nov 13, 2026, NDA 20549 (Flovent), held by Glaxosmithkline, was first approved by FDA on Nov 7, 1997, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 1997 | Original applicationNew dosage form · Standard review | Approved |
| Flovent0.044MG/INH · powder;inhalation | Fluticasone Propionate | Discontinued |
| Flovent0.088MG/INH · powder;inhalation | Fluticasone Propionate | Discontinued |
| Flovent0.22MG/INH · powder;inhalation | Fluticasone Propionate | Discontinued |
| Mar 26, 2004 | Supplement 16Labeling · Standard review | Approved | |
| Oct 8, 2003 | Supplement 14Labeling · Standard review | Approved | |
| Jun 20, 2003 | Supplement 12Labeling · Standard review | Approved | |
| Aug 27, 2001 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Mar 29, 2001 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 19, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 1, 2000 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| May 17, 2000 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 19, 1999 | Supplement 6Labeling · Standard review | Approved | |
| Apr 23, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1998 | Supplement 2Labeling · Standard review | Approved | |
| Dec 3, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 7, 1997 | Original applicationNew dosage form · 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
