Conjugated Estrogens

Treats Moderate. ANDA 214025, held by Novast Labs. Estrogens, Conjugated.

As of Nov 15, 2026, ANDA 214025 (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Oct 15, 2025	Original application	Approved	Letter Letter

Products

3 strengths and forms


Conjugated Estrogens0.3MG · tablet;oral	Estrogens, Conjugated	Rx
Conjugated Estrogens0.45MG · tablet;oral	Estrogens, Conjugated	Rx
Conjugated Estrogens0.625MG · tablet;oral	Estrogens, Conjugated	Rx

Identifiers

Application: ANDA 214025
Drugs@FDA: Overview at FDA
Company: Novast Laboratories

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