Norethindrone And Mestranol

ANDA 70759, held by Watson Labs. Mestranol; Norethindrone.

As of Nov 15, 2026, ANDA 70759 (Norethindrone And Mestranol), held by Watson Labs, was first approved by FDA on Jul 1, 1988, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 1, 1988
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
Jul 1, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norethindrone And Mestranol0.05MG;1MG · tablet;oral-28	Mestranol; Norethindrone	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 18Labeling · Standard review	Approved	None posted
Jun 26, 2002	Supplement 10Manufacturing	Approved	None posted
May 21, 2002	Supplement 9Manufacturing	Approved	None posted
May 8, 2002	Supplement 6Labeling	Approved	None posted
Oct 4, 2001	Supplement 8Manufacturing	Approved	None posted
May 1, 1997	Supplement 5Labeling	Approved	None posted
Nov 4, 1993	Supplement 4Labeling	Approved	None posted
Aug 10, 1993	Supplement 3Manufacturing	Approved	None posted
Mar 15, 1990	Supplement 2Labeling	Approved	None posted
Jul 31, 1989	Supplement 1Labeling	Approved	None posted
Jul 1, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 70759
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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