ANDA 208272, held by Torrent. Roflumilast.
As of Nov 15, 2026, ANDA 208272 (Roflumilast), held by Torrent, was first approved by FDA on Aug 6, 2018, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2018 | Original application | Approved | None posted |
| Roflumilast500MCG · tablet;oral | Roflumilast | Discontinued |
| Roflumilast250MCG · tablet;oral | Roflumilast | Discontinued |
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
