Estradiol

Treats Moderate. ANDA 217610, held by Novitium Pharma. Estradiol.

As of Nov 14, 2026, ANDA 217610 (Estradiol), held by Novitium Pharma, was first approved by FDA on Aug 24, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 24, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Estradiol gel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 24, 2023	Original application	Approved	None posted

Products

5 strengths and forms


Estradiol0.1% (0.25GM/PACKET) · gel;transdermal	Estradiol	Rx
Estradiol0.1% (0.5GM/PACKET) · gel;transdermal	Estradiol	Rx
Estradiol0.1% (0.75GM/PACKET) · gel;transdermal	Estradiol	Rx
Estradiol0.1% (1GM/PACKET) · gel;transdermal	Estradiol	Rx
Estradiol0.1% (1.25GM/PACKET) · gel;transdermal	Estradiol	Rx

All 2 submissions, including labeling and manufacturing supplements


Jun 13, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Aug 24, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 217610
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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