Drospirenone And Ethinyl Estradiol

ANDA 202131, held by Xiromed. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 202131 (Drospirenone And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on May 4, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: May 4, 2015
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are indicated for use by females of reproductive potential to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
May 4, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Drospirenone And Ethinyl Estradiol3MG;0.03MG · tablet;oral-28	Drospirenone; Ethinyl Estradiol	Rx

All 6 submissions, including labeling and manufacturing supplements


Oct 24, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 12Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 2Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 6Labeling · Standard review	Approved	None posted
May 4, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202131
Drugs@FDA: Overview at FDA
Company: Xiromed

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