Norminest Fe

NDA 17948, held by Gd Searle LLC. Ethinyl Estradiol;Norethindrone; Ferrous Fumarate.

As of Nov 13, 2026, NDA 17948 (Norminest Fe), held by Gd Searle LLC, was first approved by FDA on Feb 21, 1978, with 32 approved supplements and 0 published complete response letters.

First approved: Feb 21, 1978
Review: Standard
Supplements approved: 32
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below

Date	Submission	Status	Documents
Feb 21, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Norminest Fe0.035MG;0.5MG;75MG · tablet;oral	Ethinyl Estradiol;Norethindrone; Ferrous Fumarate	Discontinued

All 33 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 29, 2022	Supplement 47Labeling · Standard review	Approved	Letter Label
May 8, 2019	Supplement 46Labeling · Standard review	Approved	Label Letter
Mar 20, 2018	Supplement 45Labeling · Standard review	Approved	Letter Review
Aug 9, 2017	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 2, 1995	Supplement 43Labeling · Standard review	Approved	None posted
Jul 31, 1992	Supplement 42Manufacturing	Approved	None posted
Nov 2, 1990	Supplement 35Labeling	Approved	None posted
Sep 19, 1990	Supplement 40Manufacturing	Approved	None posted
Sep 13, 1990	Supplement 39Manufacturing	Approved	None posted
Oct 24, 1989	Supplement 38Manufacturing	Approved	None posted
Jul 14, 1989	Supplement 37Manufacturing	Approved	None posted
Mar 31, 1988	Supplement 36Manufacturing	Approved	None posted
Nov 13, 1984	Supplement 33Manufacturing	Approved	None posted
Sep 27, 1984	Supplement 31Manufacturing	Approved	None posted
Jun 12, 1984	Supplement 32Labeling	Approved	None posted
May 16, 1984	Supplement 29Manufacturing	Approved	None posted
Aug 10, 1981	Supplement 25Labeling	Approved	None posted
Aug 10, 1981	Supplement 24Manufacturing	Approved	None posted
Aug 10, 1981	Supplement 23Labeling	Approved	None posted
Aug 10, 1981	Supplement 22Manufacturing	Approved	None posted
Aug 10, 1981	Supplement 21Labeling	Approved	None posted
Aug 10, 1981	Supplement 20Manufacturing	Approved	None posted
Apr 14, 1981	Supplement 19Manufacturing	Approved	None posted
Dec 18, 1980	Supplement 18Manufacturing	Approved	None posted
Dec 18, 1980	Supplement 17Manufacturing	Approved	None posted
May 13, 1980	Supplement 12Labeling	Approved	None posted
May 13, 1980	Supplement 11Manufacturing	Approved	None posted
May 13, 1980	Supplement 10Labeling	Approved	None posted
Jul 18, 1979	Supplement 5Manufacturing	Approved	None posted
Nov 6, 1978	Supplement 4Manufacturing	Approved	None posted
Nov 6, 1978	Supplement 3Manufacturing	Approved	None posted
May 26, 1978	Supplement 2Manufacturing	Approved	None posted
Feb 21, 1978	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17948
Drugs@FDA: Overview at FDA
Company: G.D. Searle

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