Treats moderate to severe vasomotor symptoms due to menopause. ANDA 216160, held by Solaris Pharma Corp. Estradiol.
As of Nov 14, 2026, ANDA 216160 (Estradiol), held by Solaris Pharma Corp, was first approved by FDA on Apr 22, 2024, with 0 approved supplements and 0 published complete response letters.
Estradiol gel, 0.06% is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. 1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitation of Use When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estradiol0.06% (1.25GM/ACTIVATION) · gel, metered;transdermal | Estradiol | Rx |
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
