NDA 22203, held by Viatris. Azelastine Hydrochloride.
As of Nov 13, 2026, NDA 22203 (Astepro), held by Viatris, was first approved by FDA on Oct 15, 2008, with 9 approved supplements and 0 published complete response letters.
| Feb 20, 2015 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Feb 20, 2015 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Aug 30, 2013 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Oct 15, 2008 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Astepro0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · spray, metered;nasal | Azelastine Hydrochloride | DiscontinuedReference drug |
| Astepro0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | Discontinued |
| Jun 28, 2021 | Supplement 18Labeling · Standard review | Approved | |
| Sep 6, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Sep 25, 2015 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 20, 2015 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Feb 20, 2015 | Supplement 10Efficacy (new indication or use) · Priority review | Approved | |
| Mar 13, 2014 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 30, 2013 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 19, 2011 | Supplement 6Labeling | Approved | |
| Aug 31, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Oct 15, 2008 | Original applicationNew formulation or manufacturer · 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
