Lo Minastrin Fe

NDA 204654, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 204654 (Lo Minastrin Fe), held by Apil, was first approved by FDA on Jul 24, 2013, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2013
Review: Standard
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 24, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lo Minastrin Fe0.01MG,0.01MG,N/A;1MG,N/A,N/A · tablet, chewable, tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug

All 6 submissions, including labeling and manufacturing supplements


Aug 9, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Jun 28, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Oct 7, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
May 20, 2014	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 16, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 24, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 204654
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