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As of Nov 14, 2026, NDA 212122 (Breztri Aerosphere), held by Astrazeneca AB, was first approved by FDA on Jul 23, 2020, with 2 approved supplements and 1 published complete response letter.
First approved: Jul 23, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 1
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 3 submissions below
Apr 27, 2026
Supplement 9Efficacy (new indication or use) · Standard review
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
