Lowers the risk of COPD exacerbations. ANDA 208299, held by Prinston. Roflumilast.
As of Nov 15, 2026, ANDA 208299 (Roflumilast), held by Prinston, was first approved by FDA on May 10, 2022, with 1 approved supplement and 0 published complete response letters.
Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Limitations of Use Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Jun 6, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 10, 2022 | Original application | 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
