NDA 22474, held by Lab Hra Pharma. Ulipristal Acetate.
As of Nov 14, 2026, NDA 22474 (Ella), held by Lab Hra Pharma, was first approved by FDA on Aug 13, 2010, with 8 approved supplements and 0 published complete response letters.
Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Ella is not intended for routine use as a contraceptive.
| Jun 24, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Aug 13, 2010 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ella30MG · tablet;oral | Ulipristal Acetate | RxReference drug |
| Jun 24, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Apr 7, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Mar 10, 2015 | Supplement 7Labeling · Standard review | Approved | |
| Aug 28, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Jun 27, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2014 | Supplement 4Labeling · Standard review | Approved | |
| May 2, 2012 | Supplement 2Labeling · Standard review | Approved | |
| Aug 13, 2010 | Original applicationNew molecular entity · 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
