Treats moderate to severe vasomotor symptoms associated with the menopause. ANDA 40275, held by Epic Pharma LLC. Estradiol.
As of Nov 14, 2026, ANDA 40275 (Estradiol), held by Epic Pharma LLC, was first approved by FDA on Dec 29, 1998, with 6 approved supplements and 0 published complete response letters.
Estradiol tablets are indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. 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. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease. 5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). 6. Prevention of osteoporosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 29, 1998 | Original application | Approved |
| Jan 22, 2026 | Supplement 14Labeling · Standard review | Approved | None posted |
| Feb 16, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jan 4, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Nov 1, 1999 | Supplement 2Labeling | Approved | None posted |
| Nov 1, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Sep 24, 1999 | Supplement 3Labeling | Approved | None posted |
| Dec 29, 1998 | Original application | Approved |
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
