ANDA 208257, held by Pharmobedient. Roflumilast.
As of Nov 15, 2026, ANDA 208257 (Roflumilast), held by Pharmobedient, was first approved by FDA on Jul 13, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Roflumilast500MCG · tablet;oral | Roflumilast | Discontinued |
| Dec 22, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 22, 2021 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 13, 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
