Drospirenone And Ethinyl Estradiol

ANDA 205876, held by Apotex. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 205876 (Drospirenone And Ethinyl Estradiol), held by Apotex, was first approved by FDA on Sep 21, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 21, 2016
Review: Standard
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
Sep 21, 2016	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	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 12, 2023	Supplement 7Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 6Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Sep 21, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 205876
Drugs@FDA: Overview at FDA
Company: Apotex

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