ANDA 207243, held by Hikma. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 207243 (Azelastine Hydrochloride), held by Hikma, was first approved by FDA on Sep 22, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 22, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | Discontinued |
| Dec 12, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 22, 2017 | Original application | Approved | None posted |
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
