Treats moderate to severe vasomotor symptoms due to menopause. NDA 22014, held by Padagis US. Estradiol.
As of Nov 14, 2026, NDA 22014 (Evamist), held by Padagis US, was first approved by FDA on Jul 27, 2007, with 8 approved supplements and 0 published complete response letters.
Evamist is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 27, 2007 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Evamist1.53MG/SPRAY · spray;transdermal | Estradiol | RxReference drug |
| Feb 15, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Aug 3, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Mar 11, 2014 | Supplement 6Labeling · Standard review | Approved | |
| Jan 15, 2013 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 26, 2011 | Supplement 9Labeling | Approved | |
| Oct 30, 2008 | Supplement 5Labeling · Standard review | Approved | |
| Apr 11, 2008 | Supplement 1Labeling · Standard review | Approved | |
| Jul 27, 2007 | Original applicationNew formulation or manufacturer · 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
