Drospirenone And Ethinyl Estradiol

ANDA 213034, held by Hetero Labs. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 213034 (Drospirenone And Ethinyl Estradiol), held by Hetero Labs, was first approved by FDA on Jan 24, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Drospirenone and ethinyl estradiol tablets are use by females of reproductive potential to prevent pregnancy. Drospirenone and ethinyl estradiol tablets are a combination of a progestin and ethinyl estradiol, 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 3 submissions below

Date	Submission	Status	Documents
Jan 24, 2020	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 3 submissions, including labeling and manufacturing supplements


Dec 26, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Dec 26, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jan 24, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213034
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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