Drospirenone And Ethinyl Estradiol

ANDA 90081, held by Dr Reddys Labs SA. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 90081 (Drospirenone And Ethinyl Estradiol), held by Dr Reddys Labs SA, was first approved by FDA on Sep 7, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 7, 2010
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
Sep 7, 2010	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	Rx

All 5 submissions, including labeling and manufacturing supplements


Feb 5, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Apr 27, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Apr 27, 2023	Supplement 20Labeling · Standard review	Approved	None posted
May 29, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 7, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 90081
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's 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