Treats Moderate. ANDA 202985, held by Zydus Pharms. Estradiol.
As of Nov 14, 2026, ANDA 202985 (Estradiol), held by Zydus Pharms, was first approved by FDA on Mar 29, 2023, with 1 approved supplement and 0 published complete response letters.
Estradiol Transdermal System is indicated for: Estradiol Transdermal System, USP 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 symptoms of vulvar and vaginal atrophy due to menopause, first consider the use of topical vaginal products.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 29, 2023 | Original application | Approved | None posted |
| Estradiol0.025MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Estradiol0.0375MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Estradiol0.05MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Estradiol0.06MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Estradiol0.075MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Estradiol0.1MG/24HR · film, extended release;transdermal | Estradiol | Rx |
| Aug 19, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 29, 2023 | 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
