Treats moderate to severe vasomotor symptoms due to menopause. ANDA 217882, held by Novitium Pharma. Estradiol.
As of Nov 14, 2026, ANDA 217882 (Estradiol), held by Novitium Pharma, was first approved by FDA on Oct 23, 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 |
|---|---|---|---|
| Oct 23, 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
