ANDA 216421, held by Apotex. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 216421 (Azelastine Hydrochloride Allergy, Azelastine Hydrochloride Children'S Allergy), held by Apotex, was first approved by FDA on May 29, 2024, with 0 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion sneezing runny nose itchy nose
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 29, 2024 | Original application | Approved |
| Azelastine Hydrochloride Allergy0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | OTC |
| Azelastine Hydrochloride Children'S Allergy0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | OTC |
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
