Loestrin Fe 1/20

NDA 17354, held by Teva Branded Pharm. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 17354 (Loestrin Fe 1/20), held by Teva Branded Pharm, was first approved by FDA on Apr 30, 1973, with 37 approved supplements and 0 published complete response letters.

First approved: Apr 30, 1973
Review: Priority
Supplements approved: 37
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below

Date	Submission	Status	Documents
Apr 30, 1973	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loestrin Fe 1/200.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-28	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Jan 4, 2023	Supplement 55Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 54Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 51Labeling · Standard review	Approved	Letter Label
Jan 14, 2016	Supplement 48Manufacturing · Priority review	Approved	None posted
Sep 26, 2014	Supplement 47Manufacturing · Priority review	Approved	None posted
Aug 1, 2014	Supplement 46Manufacturing · Priority review	Approved	None posted
Jul 31, 2014	Supplement 45Manufacturing · Priority review	Approved	Label
May 2, 2003	Supplement 44Labeling · Standard review	Approved	Letter
Nov 24, 1999	Supplement 42Labeling · Standard review	Approved	None posted
Mar 31, 1999	Supplement 43Labeling · Standard review	Approved	None posted
Jan 8, 1999	Supplement 41Labeling · Standard review	Approved	None posted
Jan 16, 1998	Supplement 40Labeling · Standard review	Approved	None posted
Nov 20, 1997	Supplement 39Manufacturing · Priority review	Approved	None posted
Jul 28, 1997	Supplement 38Manufacturing · Priority review	Approved	None posted
Jul 28, 1997	Supplement 37Manufacturing · Priority review	Approved	None posted
Mar 8, 1996	Supplement 33Labeling · Standard review	Approved	None posted
Mar 8, 1996	Supplement 30Labeling	Approved	None posted
Jul 7, 1995	Supplement 36Manufacturing · Priority review	Approved	None posted
Jun 27, 1994	Supplement 34Manufacturing · Priority review	Approved	None posted
Jun 2, 1994	Supplement 35Manufacturing · Priority review	Approved	None posted
Mar 7, 1994	Supplement 32Manufacturing · Priority review	Approved	None posted
Jul 9, 1993	Supplement 31Manufacturing · Priority review	Approved	None posted
Apr 22, 1991	Supplement 29Labeling	Approved	None posted
May 17, 1989	Supplement 28Manufacturing · Priority review	Approved	None posted
Sep 13, 1988	Supplement 26Labeling	Approved	None posted
Mar 16, 1988	Supplement 27Manufacturing · Priority review	Approved	None posted
Oct 22, 1986	Supplement 25Manufacturing · Priority review	Approved	None posted
Jun 4, 1986	Supplement 24Labeling	Approved	None posted
Sep 17, 1985	Supplement 22Manufacturing · Priority review	Approved	None posted
Oct 22, 1984	Supplement 23Labeling	Approved	None posted
Nov 18, 1982	Supplement 21Manufacturing · Priority review	Approved	None posted
Apr 9, 1981	Supplement 19Labeling	Approved	None posted
Jun 14, 1978	Supplement 16Manufacturing · Priority review	Approved	None posted
Nov 22, 1977	Supplement 17Labeling	Approved	None posted
Feb 8, 1977	Supplement 13Manufacturing · Priority review	Approved	None posted
Feb 8, 1977	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 11, 1975	Supplement 10Labeling	Approved	None posted
Apr 30, 1973	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 17354
Drugs@FDA: Overview at FDA
Company: Teva Branded Pharmaceutical Products

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