Drospirenone And Ethinyl Estradiol

ANDA 211944, held by Hetero Labs. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 211944 (Drospirenone And Ethinyl Estradiol), held by Hetero Labs, was first approved by FDA on Mar 22, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 22, 2019
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 a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to:

Prevent pregnancy.
Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception.
Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1.1 Oral Contraceptive

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
Mar 22, 2019	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Aug 16, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Aug 16, 2023	Supplement 5Labeling · Standard review	Approved	None posted
Mar 22, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 211944
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