ANDA 201846, held by Apotex Inc. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 201846 (Azelastine Hydrochloride), held by Apotex Inc, was first approved by FDA on Aug 31, 2012, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | Discontinued |
| Nov 4, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 5, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 5, 2017 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 31, 2012 | Original application | 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
