Desogestrel And Ethinyl Estradiol

ANDA 202085, held by Xiromed. Desogestrel; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 202085 (Desogestrel And Ethinyl Estradiol), held by Xiromed, was first approved by FDA on May 20, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: May 20, 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
May 20, 2015	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Desogestrel And Ethinyl Estradiol0.15MG;0.03MG · tablet;oral-28	Desogestrel; Ethinyl Estradiol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 6Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 3Labeling · Standard review	Approved	None posted
May 26, 2016	Supplement 1Labeling · Standard review	Approved	None posted
May 20, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 202085
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