Loestrin 21 1/20

NDA 17876, held by Teva Branded Pharm. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 17876 (Loestrin 21 1/20), held by Teva Branded Pharm, was first approved by FDA on Oct 1, 1976, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 1, 1976
Review: Standard
Supplements approved: 31
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below

Date	Submission	Status	Documents
Oct 1, 1976	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loestrin 21 1/200.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral-21	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug

All 32 submissions, including labeling and manufacturing supplements


Jan 4, 2023	Supplement 40Labeling · Standard review	Approved	Label Letter Letter
Apr 29, 2022	Supplement 39Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 36Labeling · Standard review	Approved	Letter Label
Sep 26, 2014	Supplement 33Manufacturing · Standard review	Approved	None posted
May 2, 2003	Supplement 31Labeling · Standard review	Approved	Letter
Nov 24, 1999	Supplement 29Labeling · Standard review	Approved	None posted
Mar 31, 1999	Supplement 30Labeling · Standard review	Approved	None posted
Jan 8, 1999	Supplement 28Labeling · Standard review	Approved	None posted
Jan 16, 1998	Supplement 27Labeling · Standard review	Approved	None posted
Nov 20, 1997	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 28, 1997	Supplement 25Manufacturing · Standard review	Approved	None posted
Jul 28, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 8, 1996	Supplement 20Labeling · Standard review	Approved	None posted
Mar 8, 1996	Supplement 17Labeling	Approved	None posted
Jul 7, 1995	Supplement 23Manufacturing · Standard review	Approved	None posted
Jun 27, 1994	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 2, 1994	Supplement 22Manufacturing · Standard review	Approved	None posted
Mar 7, 1994	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 9, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 22, 1991	Supplement 16Labeling	Approved	None posted
May 17, 1989	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 13, 1988	Supplement 13Labeling	Approved	None posted
Mar 16, 1988	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 4, 1986	Supplement 12Labeling	Approved	None posted
Sep 17, 1985	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 22, 1984	Supplement 11Labeling	Approved	None posted
Nov 18, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Jun 14, 1978	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 10, 1977	Supplement 5Labeling	Approved	None posted
Feb 9, 1977	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 9, 1977	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 1, 1976	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 17876
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