NDA 22027, held by Schering. Posaconazole.
As of Nov 14, 2026, NDA 22027 (Noxafil), held by Schering, was first approved by FDA on Oct 20, 2006, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 20, 2006 | Original applicationTYPE 6 | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Noxafil40MG/ML · suspension; oral | Posaconazole | Rx |
| Jun 21, 2012 | Supplement 2Labeling · Standard review | Approved | |
| Jun 21, 2012 | Supplement 3Labeling | Approved | |
| Sep 8, 2010 | Supplement 1Labeling · Standard review | Approved | |
| Oct 20, 2006 | Original applicationTYPE 6 | 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