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Treats moderate to severe vasomotor symptoms due to menopause. ANDA 216055, held by Amneal. Estradiol.
As of Nov 14, 2026, ANDA 216055 (Estradiol), held by Amneal, was first approved by FDA on Jul 12, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Jul 12, 2024
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
