NDA 21152, held by Fougera. Fluticasone Propionate.
As of Nov 14, 2026, NDA 21152 (Cutivate), held by Fougera, was first approved by FDA on Mar 31, 2005, with 7 approved supplements and 0 published complete response letters.
| Jan 16, 2015 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 31, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cutivate0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · lotion;topical | Fluticasone Propionate | DiscontinuedReference drug |
| Jan 16, 2015 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2014 | Supplement 3Manufacturing | Approved | None posted |
| Nov 17, 2014 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Apr 24, 2013 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 1, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 12, 2011 | Supplement 5Labeling | Approved | |
| Sep 3, 2010 | Supplement 2Labeling · Standard review | Approved | |
| Mar 31, 2005 | Original applicationNew dosage form · Standard review | 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
