Estrostep 21, Estrostep Fe

NDA 20130, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 20130 (Estrostep 21, Estrostep Fe), held by Apil, was first approved by FDA on Oct 9, 1996, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 9, 1996
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Oct 9, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms


Estrostep 210.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug
Estrostep Fe0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 22Labeling · Standard review	Approved	Label Letter
Jul 14, 2021	Supplement 21Labeling · Standard review	Approved	Label Letter
Oct 10, 2017	Supplement 18Labeling · Standard review	Approved	Letter Label
Aug 9, 2017	Supplement 17Labeling · Standard review	Approved	Letter Label
Sep 3, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 30, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Sep 12, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 14, 2002	Supplement 9Labeling · Standard review	Approved	Letter
Mar 8, 2002	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 1, 2001	Supplement 7Labeling · Standard review	Approved	Label
Oct 25, 1999	Supplement 5Labeling · Standard review	Approved	None posted
May 7, 1999	Supplement 3Labeling · Standard review	Approved	Review
Mar 31, 1999	Supplement 6Labeling · Standard review	Approved	None posted
Jan 9, 1998	Supplement 2Labeling · Standard review	Approved	None posted
Sep 23, 1997	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 9, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20130
Drugs@FDA: Overview at FDA
Company: APIL

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