NDA 18533, held by Janssen Pharms. Ketoconazole.
As of Nov 13, 2026, NDA 18533 (Nizoral), held by Janssen Pharms, was first approved by FDA on Jun 12, 1981, with 38 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 1981 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nizoral200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Ketoconazole | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2014 | Supplement 41Labeling · Priority review | Approved | |
| Jul 25, 2013 | Supplement 40Labeling · Priority review | Approved | |
| Aug 13, 2002 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Apr 1, 2002 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1999 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1999 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Jul 24, 1998 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| May 28, 1998 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Mar 17, 1998 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Jul 8, 1996 | Supplement 29Labeling · Priority review | Approved | None posted |
| Jun 14, 1996 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Apr 8, 1996 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Sep 15, 1995 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1995 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1995 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Mar 22, 1994 | Supplement 24Labeling · Priority review | Approved | None posted |
| Sep 20, 1993 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Dec 28, 1992 | Supplement 22Labeling · Priority review | Approved | None posted |
| Dec 28, 1992 | Supplement 20Labeling · Priority review | Approved | None posted |
| Oct 13, 1992 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Mar 15, 1991 | Supplement 19Labeling · Priority review | Approved | None posted |
| Apr 14, 1989 | Supplement 18Labeling · Priority review | Approved | None posted |
| Jul 8, 1988 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| May 10, 1988 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jun 30, 1986 | Supplement 14Labeling · Priority review | Approved | None posted |
| Jun 30, 1986 | Supplement 13Labeling · Priority review | Approved | None posted |
| Jun 30, 1986 | Supplement 12Labeling · Priority review | Approved | None posted |
| Jun 30, 1986 | Supplement 11Labeling · Priority review | Approved | None posted |
| Jun 30, 1986 | Supplement 3Labeling · Priority review | Approved | None posted |
| Jun 19, 1985 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1984 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jul 9, 1984 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1983 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Jun 23, 1983 | Supplement 4Labeling · Priority review | Approved | None posted |
| Jun 23, 1983 | Supplement 2Labeling · Priority review | Approved | None posted |
| Apr 15, 1983 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Apr 15, 1983 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Sep 29, 1981 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 12, 1981 | Original applicationNew molecular entity · Priority 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
