ANDA 208199, held by Amneal. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 208199 (Azelastine Hydrochloride), held by Amneal, was first approved by FDA on Dec 15, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride0.2055MG/SPRAY ยท spray, metered;nasal | Azelastine Hydrochloride | Discontinued |
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
