NDA 22371, held by Meda Pharms. Azelastine Hydrochrloride.
As of Nov 13, 2026, NDA 22371 (Astepro), held by Meda Pharms, was first approved by FDA on Aug 31, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2009 | Original applicationTYPE 6 · Standard review | Approved |
| Astepro0.1% · spray, metered;nasal | Azelastine Hydrochrloride | Rx |
| Astepro0.15% · spray, metered;nasal | Azelastine Hydrochrloride | Rx |
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
