Drospirenone And Ethinyl Estradiol

ANDA 202594, held by Xiromed. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 202594 (Drospirenone And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on Oct 22, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Oct 22, 2015
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Oct 22, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Drospirenone And Ethinyl Estradiol3MG;0.02MG · tablet;oral	Drospirenone; Ethinyl Estradiol	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 24, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Jun 4, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Oct 22, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202594
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