Lowers the risk of COPD exacerbations. ANDA 208180, held by Micro Labs. Roflumilast.
As of Nov 15, 2026, ANDA 208180 (Roflumilast), held by Micro Labs, was first approved by FDA on Mar 22, 2019, with 0 approved supplements and 0 published complete response letters.
Roflumilast tablets are 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 tablet 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 |
|---|---|---|---|
| Mar 22, 2019 | Original application | Approved |
| Roflumilast500MCG · tablet;oral | Roflumilast | Rx |
| Roflumilast250MCG · tablet;oral | Roflumilast | Rx |
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
