Syeda

ANDA 90114, held by Xiromed. Drospirenone; Ethinyl Estradiol.

As of Nov 15, 2026, ANDA 90114 (Syeda), held by Xiromed, was first approved by FDA on Mar 28, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 28, 2011
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Syeda (drospirenone and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Syeda (drospirenone and ethinyl estradiol tablets) is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 28, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Syeda3MG;0.03MG · tablet;oral-28	Drospirenone; Ethinyl Estradiol	Rx

All 7 submissions, including labeling and manufacturing supplements


Sep 22, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Apr 20, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Apr 20, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Apr 20, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jun 13, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Aug 2, 2011	Supplement 1Labeling	Approved	None posted
Mar 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90114
Drugs@FDA: Overview at FDA
Company: Xiromed

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