Drospirenone And Ethinyl Estradiol

ANDA 201663, held by Lupin Ltd. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 201663 (Drospirenone And Ethinyl Estradiol), held by Lupin Ltd, was first approved by FDA on Dec 18, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 18, 2012
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Drospirenone and ethinyl estradiol tablet USP is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, 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 5 submissions below

Date	Submission	Status	Documents
Dec 18, 2012	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 5 submissions, including labeling and manufacturing supplements


Oct 23, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jun 19, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jun 19, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Dec 18, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201663
Drugs@FDA: Overview at FDA
Company: Lupin

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