ANDA 202609, held by Padagis US. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 202609 (Azelastine Hydrochloride), held by Padagis US, was first approved by FDA on Mar 17, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride0.137MG/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
