Treats moderate to severe vasomotor symptoms due to menopause. ANDA 206241, held by Zydus Pharms. Estradiol.
As of Nov 14, 2026, ANDA 206241 (Estradiol), held by Zydus Pharms, was first approved by FDA on Dec 1, 2022, with 1 approved supplement and 0 published complete response letters.
Estradiol transdermal system, USP (twice-weekly) is indicated for: Estradiol transdermal system, USP (twice-weekly) 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 Limitations of Use When prescribing solely for the treatment of moderate to severe vaginal atrophy, first consider the use of topical vaginal products.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 1, 2022 | Original application | Approved | None posted |
| Aug 26, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 1, 2022 | Original application | Approved | None posted |
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
