NDA 22045, held by Bayer Hlthcare. Drospirenone; Ethinyl Estradiol.
As of Nov 14, 2026, NDA 22045 (Yaz), held by Bayer Hlthcare, was first approved by FDA on Jan 26, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Yaz3MG; 0.02MG · tablet; oral | Drospirenone; Ethinyl Estradiol | 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