NDA 20687, held by Danco Labs LLC. Mifepristone.
As of Nov 14, 2026, NDA 20687 (Mifeprex), held by Danco Labs LLC, was first approved by FDA on Sep 28, 2000, with 15 approved supplements and 0 published complete response letters.
| Mar 29, 2016 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2000 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mifeprex200MG · tablet;oral | Mifepristone | RxReference drug |
| Sep 30, 2025 | Supplement 27REMS | Approved | |
| Mar 23, 2023 | Supplement 26REMS | Approved | |
| Jan 3, 2023 | Supplement 25REMS | Approved | |
| May 14, 2021 | Supplement 24REMS | Approved | |
| Apr 11, 2019 | Supplement 22REMS | Approved | |
| Aug 5, 2016 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Mar 29, 2016 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Mar 10, 2016 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Mar 26, 2013 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Jun 8, 2011 | Supplement 14Labeling · Standard review | Approved | |
| Apr 24, 2009 | Supplement 15Labeling · Standard review | Approved | |
| Jul 19, 2005 | Supplement 13Labeling · Standard review | Approved | |
| Dec 22, 2004 | Supplement 11Labeling · Standard review | Approved | |
| Nov 15, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Mar 29, 2002 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 28, 2000 | Original applicationNew molecular entity · Priority 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
