Drospirenone And Ethinyl Estradiol

ANDA 78515, held by Barr. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 78515 (Drospirenone And Ethinyl Estradiol), held by Barr, was first approved by FDA on Mar 30, 2009, with 4 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2009
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Mar 30, 2009	Original application	Approved	Letter Label

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Oct 6, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Jul 2, 2010	Supplement 5Labeling	Approved	None posted
Jul 2, 2010	Supplement 7Labeling	Approved	None posted
Mar 30, 2009	Original application	Approved	Letter Label

Identifiers

Application: ANDA 78515
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