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Treats moderate to severe vasomotor symptoms due to menopause. ANDA 211783, held by Xiromed. Estradiol.
As of Nov 14, 2026, ANDA 211783 (Estradiol), held by Xiromed, was first approved by FDA on Aug 10, 2022, with 0 approved supplements and 0 published complete response letters.
First approved: Aug 10, 2022
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Estradiol gel 0.1% 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
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
