Norethin 1/50m-28

ANDA 71540, held by Heritage Pharma. Mestranol; Norethindrone.

As of Nov 15, 2026, ANDA 71540 (Norethin 1/50m-28), held by Heritage Pharma, was first approved by FDA on Apr 12, 1988, with 12 approved supplements and 0 published complete response letters.

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

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 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-280.05MG;1MG · tablet;oral-28	Mestranol; Norethindrone	Discontinued

All 13 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 14Labeling · Standard review	Approved	None posted
Jul 11, 1997	Supplement 13Labeling	Approved	None posted
Jan 13, 1997	Supplement 11Manufacturing	Approved	None posted
Jan 13, 1997	Supplement 12Manufacturing	Approved	None posted
Dec 23, 1993	Supplement 10Manufacturing	Approved	None posted
Aug 28, 1992	Supplement 8Labeling	Approved	None posted
May 1, 1992	Supplement 9Labeling	Approved	None posted
Oct 11, 1991	Supplement 7Labeling	Approved	None posted
Sep 9, 1991	Supplement 6Manufacturing	Approved	None posted
Jun 19, 1991	Supplement 4Manufacturing	Approved	None posted
May 28, 1991	Supplement 5Labeling	Approved	None posted
Mar 22, 1991	Supplement 2Manufacturing	Approved	None posted
Apr 12, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71540
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