ANDA 208125, held by Lupin. Clobetasol Propionate.
As of Nov 15, 2026, ANDA 208125 (Clobetasol Propionate), held by Lupin, was first approved by FDA on Mar 26, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clobetasol Propionate0.05% · spray;topical | Clobetasol Propionate | Discontinued |
| Sep 6, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 26, 2018 | Original application | Approved | None posted |
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
