Femcon Fe

NDA 21490, held by Apil. Ethinyl Estradiol; Norethindrone.

As of Nov 14, 2026, NDA 21490 (Femcon Fe), held by Apil, was first approved by FDA on Nov 14, 2003, with 10 approved supplements and 0 published complete response letters.

First approved: Nov 14, 2003
Review: Standard
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Nov 14, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Femcon Fe0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ethinyl Estradiol; Norethindrone	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Aug 9, 2017	Supplement 19Labeling · Standard review	Approved	Letter Label
Sep 22, 2016	Supplement 10Labeling · Standard review	Approved	Letter Label
Jul 8, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 22, 2015	Supplement 16Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 5, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 6, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 1, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 9, 2008	Supplement 7Labeling · Standard review	Approved	Label Letter
Jan 29, 2007	Supplement 5Manufacturing · Standard review	Approved	Letter Label
Nov 14, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21490
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