Prevents bronchoconstriction. NDA 214070, held by Astrazeneca. Albuterol Sulfate; Budesonide.
As of Nov 13, 2026, NDA 214070 (Airsupra), held by Astrazeneca, was first approved by FDA on Jan 10, 2023, with 1 approved supplement and 0 published complete response letters.
AIRSUPRA is indicated for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2025 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2023 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AirsupraEQ 0.09MG BASE/INH;0.08MG/INH · aerosol, metered;inhalation | Albuterol Sulfate; Budesonide | RxReference drug |
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
