NDA 213872, held by Bayer Hlthcare. Azelastine Hydrochloride.
As of Nov 13, 2026, NDA 213872 (Astepro Allergy, Children'S Astepro Allergy), held by Bayer Hlthcare, was first approved by FDA on Jun 17, 2021, with 3 approved supplements and 0 published complete response letters.
Uses Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2021 | Original applicationTYPE 8 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Astepro Allergy0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | OTCReference drug |
| Children'S Astepro Allergy0.2055MG/SPRAY · spray, metered;nasal | Azelastine Hydrochloride | OTCReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 27, 2025 | Supplement 5Labeling · Standard review | Approved | |
| Nov 20, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Nov 1, 2021 | Supplement 1Manufacturing | Approved | |
| Jun 17, 2021 | Original applicationTYPE 8 · Standard review | 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
