Yaz

NDA 21676, held by Bayer Hlthcare. Drospirenone; Ethinyl Estradiol.

As of Nov 14, 2026, NDA 21676 (Yaz), held by Bayer Hlthcare, was first approved by FDA on Mar 16, 2006, with 12 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2006
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Yaz is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to:

Prevent pregnancy.
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception.
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1.1 Oral Contraceptive

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Mar 11, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 16, 2006	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Yaz3MG;0.02MG · tablet;oral	Drospirenone; Ethinyl Estradiol	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


May 19, 2023	Supplement 20Labeling · Standard review	Approved	Letter Label
Apr 29, 2022	Supplement 21Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 4, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 31, 2015	Supplement 17Manufacturing · Standard review	Approved	None posted
Jun 1, 2015	Supplement 14Labeling · Standard review	Approved	Label Letter
Sep 30, 2014	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 31, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 10, 2012	Supplement 12Labeling · Standard review	Approved	Review Letter Label
Mar 11, 2011	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 7, 2010	Supplement 9Labeling	Approved	Label Letter
Jan 26, 2007	Supplement 2Labeling · Standard review	Approved	Letter
Mar 16, 2006	Original applicationNew active ingredient · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21676
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

Yaz