Norgestrel And Ethinyl Estradiol

ANDA 201828, held by Mylan Labs Ltd. Ethinyl Estradiol; Norgestrel.

As of Nov 15, 2026, ANDA 201828 (Norgestrel And Ethinyl Estradiol), held by Mylan Labs Ltd, was first approved by FDA on Jun 21, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 21, 2016
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 21, 2016	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norgestrel And Ethinyl Estradiol0.03MG;0.3MG · tablet;oral-28	Ethinyl Estradiol; Norgestrel	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Aug 9, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Jun 21, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 201828
Drugs@FDA: Overview at FDA
Company: Mylan Laboratories

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