Lowers the risk of COPD exacerbations. ANDA 208213, held by Hetero Labs Ltd Iii. Roflumilast.
As of Nov 15, 2026, ANDA 208213 (Roflumilast), held by Hetero Labs Ltd Iii, was first approved by FDA on Nov 23, 2018, with 1 approved supplement and 0 published complete response letters.
Roflumilast tablet 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 tablet is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Roflumilast 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2018 | Original application | Approved |
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
| Apr 4, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 23, 2018 | 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
