NDA 21674, held by Bayer Hlthcare. Estradiol.
As of Nov 14, 2026, NDA 21674 (Menostar), held by Bayer Hlthcare, was first approved by FDA on Jun 8, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 8, 2004 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Menostar0.014MG/24HR · system;transdermal | Estradiol | RxReference drug |
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
