Treats asthma. ANDA 210897, held by Lupin. Budesonide.
As of Nov 15, 2026, ANDA 210897 (Budesonide), held by Lupin, was first approved by FDA on Nov 9, 2018, with 1 approved supplement and 0 published complete response letters.
Budesonide inhalation suspension is an inhaled corticosteroid indicated for: Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age Limitations of Use: Not indicated for the relief of acute bronchospasm 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 9, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Budesonide0.5MG/2ML · suspension;inhalation | Budesonide | Rx |
| Mar 29, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 9, 2018 | Original application | Approved | None posted |
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
