Treats Moderate. ANDA 220407, held by Zydus Pharms. Estradiol; Levonorgestrel.
As of Nov 15, 2026, ANDA 220407 (Estradiol And Levonorgestrel), held by Zydus Pharms, was first approved by FDA on Oct 19, 2026, with 0 approved supplements and 0 published complete response letters.
Estradiol and Levonorgestrel Transdermal System is indicated for: Estradiol and Levonorgestrel Transdermal System is an estrogen plus progestin indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Prevention of Postmenopausal Osteoporosis Limitations of Use: When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Estradiol And Levonorgestrel0.045MG/24HR;0.015MG/24HR · film, extended release;transdermal | Estradiol; Levonorgestrel | 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
