Treats moderate to severe vasomotor symptoms associated with the menopause. ANDA 217334, held by Novitium Pharma. Estradiol.
As of Nov 14, 2026, ANDA 217334 (Estradiol), held by Novitium Pharma, was first approved by FDA on Sep 6, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Estradiol tablets are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Prevention of osteoporosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 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
