NDA 21098, held by Bayer Hlthcare. Drospirenone; Ethinyl Estradiol.
As of Nov 15, 2026, NDA 21098 (Yasmin), held by Bayer Hlthcare, was first approved by FDA on May 11, 2001, with 17 approved supplements and 0 published complete response letters.
Yasmin is indicated for use by females of reproductive potential to prevent pregnancy.
| Feb 13, 2012 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| May 9, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| May 11, 2001 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Yasmin3MG;0.03MG · tablet;oral-28 | Drospirenone; Ethinyl Estradiol | RxReference drug |
| May 19, 2023 | Supplement 29Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 30Labeling · Standard review | Approved | |
| Aug 9, 2017 | Supplement 28Labeling · Standard review | Approved | |
| Mar 8, 2016 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jun 1, 2015 | Supplement 23Labeling · Standard review | Approved | |
| Nov 26, 2014 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Sep 30, 2014 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2013 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 10, 2012 | Supplement 22Labeling · Standard review | Approved | |
| Feb 13, 2012 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2010 | Supplement 17Labeling | Approved | |
| May 9, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Dec 12, 2001 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2001 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 30, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Nov 26, 2001 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| May 11, 2001 | Original applicationNew molecular entity, new combination · Standard review | Approved |
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
