NDA 20694, held by Janssen Pharma. Itraconazole.
As of Nov 13, 2026, NDA 20694 (Sporanox), held by Janssen Pharma, was first approved by FDA on Dec 6, 1996, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 6, 1996 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sporanox100MG · capsule; oral | Itraconazole | Rx |
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
