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As of Nov 15, 2026, ANDA 214023 (Conjugated Estrogens), held by Novast Labs, was first approved by FDA on Oct 15, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Oct 15, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Conjugated estrogens tablets is a mixture of estrogens indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause.
Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause
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 Postmenopausal Osteoporosis 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause 1.
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
