Norethin 1/50m-21

ANDA 71539, held by Heritage Pharma. Mestranol; Norethindrone.

As of Nov 15, 2026, ANDA 71539 (Norethin 1/50m-21), held by Heritage Pharma, was first approved by FDA on Apr 12, 1988, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 12, 1988
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 12, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norethin 1/50m-210.05MG;1MG · tablet;oral-21	Mestranol; Norethindrone	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jul 11, 1997	Supplement 9Labeling	Approved	None posted
Dec 23, 1993	Supplement 8Manufacturing	Approved	None posted
Aug 28, 1992	Supplement 7Labeling	Approved	None posted
Oct 11, 1991	Supplement 6Labeling	Approved	None posted
Sep 9, 1991	Supplement 5Manufacturing	Approved	None posted
Jun 19, 1991	Supplement 3Manufacturing	Approved	None posted
May 28, 1991	Supplement 4Labeling	Approved	None posted
Apr 12, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71539
Drugs@FDA: Overview at FDA
Company: Heritage Pharmaceuticals

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