Drospirenone And Ethinyl Estradiol

ANDA 77527, held by Barr. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 77527 (Drospirenone And Ethinyl Estradiol), held by Barr, was first approved by FDA on May 9, 2008, with 3 approved supplements and 0 published complete response letters.

First approved: May 9, 2008
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 9, 2008	Original application	Approved	Letter

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Feb 5, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Oct 9, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Oct 9, 2015	Supplement 3Labeling · Standard review	Approved	None posted
May 9, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 77527
Drugs@FDA: Overview at FDA
Company: Barr Laboratories

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