Treats atrophic vaginitis due to menopause. ANDA 216550, held by Aurobindo Pharma. Estradiol.
As of Nov 14, 2026, ANDA 216550 (Estradiol), held by Aurobindo Pharma, was first approved by FDA on Aug 2, 2024, with 0 approved supplements and 0 published complete response letters.
Estradiol vaginal inserts are an estrogen indicated for the treatment of atrophic vaginitis due to menopause 1.1 Treatment of Atrophic Vaginitis due to Menopause.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 2, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estradiol10MCG · tablet;vaginal | 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
