NDA 22057, held by Ferring. Progesterone.
As of Nov 14, 2026, NDA 22057 (Endometrin), held by Ferring, was first approved by FDA on Jun 21, 2007, with 9 approved supplements and 0 published complete response letters.
ENDOMETRIN is indicated, as part of an Assisted Reproductive Technology (ART) treatment program, to support embryo implantation in infertile women less than 35 years of age by supplementation of corpus luteal function and to maintain pregnancy after implantation up to 10 weeks.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Endometrin100MG · insert;vaginal | Progesterone | RxReference drug |
| Jul 15, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Jun 16, 2016 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 10, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2016 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Apr 21, 2014 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jun 11, 2013 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 8, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 3, 2009 | Supplement 2Labeling · Standard review | Approved | |
| Feb 26, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Jun 21, 2007 | Original applicationNew dosage form · 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
