NDA 22042, held by Lilly. Raloxifene Hydrochloride.
As of Nov 14, 2026, NDA 22042 (Evista), held by Lilly, was first approved by FDA on Sep 13, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Evista60MG · tablet; oral | Raloxifene Hydrochloride | 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