NDA 19940, held by Univ Az Cancer Ctr. Masoprocol.
As of Nov 14, 2026, NDA 19940 (Actinex), held by Univ Az Cancer Ctr, was first approved by FDA on Sep 4, 1992, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 4, 1992 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Actinex10% · cream;topical | Masoprocol | Discontinued |
| Jun 14, 1995 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1992 | 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
