ANDA 216561, held by Aurobindo Pharma. Azelastine Hydrochloride.
As of Nov 15, 2026, ANDA 216561 (Azelastine Hydrochloride Allergy), held by Aurobindo Pharma, was first approved by FDA on Jan 27, 2025, 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 ■ runny nose ■ sneezing ■ itchy nose
| Jan 27, 2025 | Original application | Approved | |
| Jan 27, 2025 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Azelastine Hydrochloride 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
