NDA 21247, held by Pharmobedient. Flunisolide.
As of Nov 14, 2026, NDA 21247 (Aerospan Hfa), held by Pharmobedient, was first approved by FDA on Jan 27, 2006, with 11 approved supplements and 0 published complete response letters.
| Aug 28, 2013 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aerospan Hfa0.078MG/INH · aerosol, metered;inhalation | Flunisolide | DiscontinuedReference drug |
| Apr 25, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Nov 17, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Jun 23, 2017 | Supplement 15Labeling · Standard review | Approved | |
| Apr 22, 2016 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 9, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Feb 9, 2015 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2014 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Dec 9, 2013 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2013 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 28, 2013 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Nov 16, 2012 | Supplement 7Labeling · Standard review | Approved | |
| Jan 27, 2006 | 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
