NDA 20966, held by Janssen Pharms. Itraconazole.
As of Nov 15, 2026, NDA 20966 (Sporanox), held by Janssen Pharms, was first approved by FDA on Mar 30, 1999, with 15 approved supplements and 0 published complete response letters.
| May 9, 2001 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 30, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sporanox10MG/ML · injectable;injection | Itraconazole | Discontinued |
| Apr 23, 2009 | Supplement 22Labeling · Standard review | Approved | |
| Mar 5, 2009 | Supplement 17Labeling · Standard review | Approved | |
| Mar 5, 2009 | Supplement 18Labeling · Standard review | Approved | |
| Mar 5, 2009 | Supplement 20Labeling · Standard review | Approved | |
| Jul 14, 2004 | Supplement 11Labeling · Standard review | Approved | |
| Oct 10, 2002 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Sep 16, 2002 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 2, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 2, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 17, 2002 | Supplement 6Labeling · Standard review | Approved | |
| Feb 28, 2002 | Supplement 5Labeling · Standard review | Approved | |
| May 9, 2001 | Supplement 1Labeling · Standard review | Approved | |
| May 9, 2001 | Supplement 3Labeling · Standard review | Approved | |
| May 9, 2001 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 25, 1999 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 30, 1999 | 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
