NDA 19828, held by Fougera. Oxiconazole Nitrate.
As of Nov 13, 2026, NDA 19828 (Oxistat), held by Fougera, was first approved by FDA on Dec 30, 1988, with 8 approved supplements and 0 published complete response letters.
| Aug 18, 1997 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Aug 18, 1997 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Dec 30, 1988 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| OxistatEQ 1% BASE · cream;topical | Oxiconazole Nitrate | RxReference drug |
| Jan 23, 2004 | Supplement 9Labeling · Standard review | Approved | |
| Aug 18, 1997 | Supplement 3Efficacy (new indication or use) | Approved | None posted |
| Aug 18, 1997 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | None posted |
| Aug 8, 1997 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1994 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1992 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | None posted |
| Nov 28, 1989 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 7, 1989 | Supplement 1Labeling | Approved | None posted |
| Dec 30, 1988 | Original applicationNew molecular entity · 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
