Treats asthma as prophylactic therapy. NDA 207921, held by Norton Waterford. Beclomethasone Dipropionate.
As of Nov 14, 2026, NDA 207921 (Qvar Redihaler), held by Norton Waterford, was first approved by FDA on Aug 3, 2017, with 2 approved supplements and 0 published complete response letters.
QVAR REDIHALER is indicated in the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: QVAR REDIHALER is not indicated for the relief of acute bronchospasm. QVAR REDIHALER is a corticosteroid indicated for maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. Limitations of Use: Not indicated for the relief of acute bronchospasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Qvar Redihaler0.04MG/INH · aerosol, metered;inhalation | Beclomethasone Dipropionate | RxReference drug |
| Qvar Redihaler0.08MG/INH · aerosol, metered;inhalation | Beclomethasone Dipropionate | RxReference drug |
| Sep 26, 2025 | Supplement 7Labeling · Standard review | Approved | |
| Jan 6, 2021 | Supplement 4Labeling · Standard review | Approved | |
| Nov 19, 2018 | Supplement 3Manufacturing | Tentative approval | |
| Aug 3, 2017 | Original applicationNew formulation or manufacturer · 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
