Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

ANDA 202742, held by Xiromed. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 15, 2026, ANDA 202742 (Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate), held by Xiromed, was first approved by FDA on Oct 30, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2014
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 30, 2014	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate0.02MG;1MG · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 30, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Apr 30, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Apr 29, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jan 28, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Nov 8, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Nov 8, 2018	Supplement 3Labeling · Standard review	Approved	None posted
Nov 8, 2018	Supplement 1Labeling · Standard review	Approved	None posted
Oct 30, 2014	Original application	Approved	None posted

Identifiers

Application: ANDA 202742
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