Drospirenone And Ethinyl Estradiol

ANDA 204848, held by Glenmark Pharms Ltd. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 204848 (Drospirenone And Ethinyl Estradiol), held by Glenmark Pharms Ltd, was first approved by FDA on Mar 25, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 25, 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	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 28, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Sep 28, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Sep 28, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Mar 25, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204848
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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