Angeliq

NDA 21355, held by Bayer Hlthcare. Drospirenone; Estradiol.

As of Nov 15, 2026, NDA 21355 (Angeliq), held by Bayer Hlthcare, was first approved by FDA on Sep 28, 2005, with 8 approved supplements and 0 published complete response letters.

First approved: Sep 28, 2005
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Angeliq is a combination of an estrogen and progestin indicated in a woman with a uterus for the treatment of: Moderate to severe vasomotor symptoms due to menopause. Moderate to severe vulvar and vaginal atrophy symptoms due to menopause.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below


Feb 29, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 28, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Angeliq0.25MG;0.5MG · tablet;oral	Drospirenone; Estradiol	RxReference drug
Angeliq0.5MG;1MG · tablet;oral	Drospirenone; Estradiol	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Feb 15, 2024	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 2, 2023	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 2, 2023	Supplement 10Labeling · Standard review	Approved	Letter Label
Nov 1, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 30, 2015	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 26, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Feb 29, 2012	Supplement 2Labeling · Standard review	Approved	Letter Label
Feb 29, 2012	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Sep 28, 2005	Original applicationNew combination · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21355
Drugs@FDA: Overview at FDA
Company: Bayer Healthcare

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