NDA 18707, held by Fougera. Alclometasone Dipropionate.
As of Nov 14, 2026, NDA 18707 (Aclovate), held by Fougera, was first approved by FDA on Dec 14, 1982, with 9 approved supplements and 0 published complete response letters.
| Apr 26, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 14, 1982 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aclovate0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Alclometasone Dipropionate | DiscontinuedReference drug |
| Apr 5, 2011 | Supplement 12Labeling · Standard review | Approved | |
| Apr 2, 2003 | Supplement 8Labeling · Standard review | Approved | |
| Jun 3, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 26, 1996 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jun 22, 1994 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1994 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 8, 1990 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 20, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1983 | Supplement 1Labeling | Approved | None posted |
| Dec 14, 1982 | Original applicationNew dosage form · Standard review | 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
