Norethindrone And Ethinyl Estradiol

ANDA 70685, held by Watson Pharms Teva. Ethinyl Estradiol; Norethindrone.

As of Nov 15, 2026, ANDA 70685 (Norethindrone And Ethinyl Estradiol), held by Watson Pharms Teva, was first approved by FDA on Jan 29, 1987, with 17 approved supplements and 0 published complete response letters.

First approved: Jan 29, 1987
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jan 29, 1987	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norethindrone And Ethinyl Estradiol0.035MG;1MG · tablet;oral-21	Ethinyl Estradiol; Norethindrone	Discontinued

All 18 submissions, including labeling and manufacturing supplements


Apr 29, 2022	Supplement 35Labeling · Standard review	Approved	None posted
Aug 9, 2017	Supplement 34Labeling · Standard review	Approved	None posted
Dec 13, 2002	Supplement 17Manufacturing	Approved	None posted
Dec 13, 2002	Supplement 16Manufacturing	Approved	None posted
Jun 26, 2002	Supplement 15Manufacturing	Approved	None posted
May 21, 2002	Supplement 13Manufacturing	Approved	None posted
May 8, 2002	Supplement 9Labeling	Approved	None posted
Oct 31, 2001	Supplement 12Manufacturing	Approved	None posted
Jan 29, 2001	Supplement 10Manufacturing	Approved	None posted
May 1, 1997	Supplement 8Labeling	Approved	None posted
Nov 4, 1993	Supplement 36Labeling	Approved	None posted
Nov 4, 1993	Supplement 7Labeling	Approved	None posted
Mar 15, 1990	Supplement 6Labeling	Approved	None posted
Jul 28, 1989	Supplement 5Labeling	Approved	None posted
Nov 19, 1987	Supplement 4Labeling	Approved	None posted
Nov 19, 1987	Supplement 3Labeling	Approved	None posted
Feb 25, 1987	Supplement 1Labeling	Approved	None posted
Jan 29, 1987	Original application	Approved	None posted

Identifiers

Application: ANDA 70685
Drugs@FDA: Overview at FDA
Company: Watson 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