Beyaz

NDA 22532, held by Bayer Hlthcare. Drospirenone; Ethinyl Estradiol; Levomefolate Calcium.

As of Nov 14, 2026, NDA 22532 (Beyaz), held by Bayer Hlthcare, was first approved by FDA on Sep 24, 2010, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 24, 2010
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, 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 females of reproductive potential at least 14 years old only if the patient desires an oral contraceptive for birth control.
Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Feb 13, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 24, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Beyaz3MG,N/A;0.02MG,N/A;0.451MG,0.451MG · tablet;oral	Drospirenone; Ethinyl Estradiol; Levomefolate Calcium	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


May 19, 2023	Supplement 10Labeling · Standard review	Approved	Letter Label
Apr 29, 2022	Supplement 11Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 9Labeling · Standard review	Approved	Letter Label
May 11, 2016	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 1, 2015	Supplement 6Labeling · Standard review	Approved	Label Letter
Apr 10, 2012	Supplement 4Labeling · Standard review	Approved	Review Letter Label
Feb 13, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Sep 24, 2010	Original applicationNew combination · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22532
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