Loestrin 24 Fe

NDA 21871, held by Teva Branded Pharm. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 14, 2026, NDA 21871 (Loestrin 24 Fe), held by Teva Branded Pharm, was first approved by FDA on Feb 17, 2006, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 17, 2006
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Feb 17, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Loestrin 24 Fe0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Jan 4, 2023	Supplement 13Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 12Labeling · Standard review	Approved	Label Letter
Sep 2, 2021	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 9, 2017	Supplement 8Labeling · Standard review	Approved	Letter Label
Aug 22, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Apr 19, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
May 1, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 10, 2010	Supplement 2Manufacturing	Approved	None posted
Feb 17, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21871
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