Femhrt

NDA 21065, held by Apil. Ethinyl Estradiol; Norethindrone Acetate.

As of Nov 13, 2026, NDA 21065 (Femhrt), held by Apil, was first approved by FDA on Oct 15, 1999, with 15 approved supplements and 0 published complete response letters.

First approved: Oct 15, 1999
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Jan 14, 2005	Supplement 12Efficacy (new indication or use)	Approved	Label Letter
Oct 15, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Label Patient Package Insert Review

Products

2 strengths and forms


Femhrt0.0025MG;0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug
Femhrt0.005MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Ethinyl Estradiol; Norethindrone Acetate	DiscontinuedReference drug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 16 submissions, including labeling and manufacturing supplements


May 18, 2023	Supplement 26Labeling · Standard review	Approved	Label Letter
May 18, 2023	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 1, 2017	Supplement 24Labeling · Standard review	Approved	Label
Mar 25, 2014	Supplement 23Manufacturing · Standard review	Approved	None posted
Jan 8, 2014	Supplement 20Labeling	Approved	Letter Label
Sep 13, 2013	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 15, 2013	Supplement 22Manufacturing · Standard review	Approved	None posted
Jan 14, 2005	Supplement 12Efficacy (new indication or use)	Approved	Label Letter
Jan 20, 2004	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 19, 2000	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 14, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Jul 14, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Jul 3, 2000	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 20, 2000	Supplement 3Labeling · Standard review	Approved	None posted
Mar 7, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 15, 1999	Original applicationNew dosage form · Standard review	Approved	Letter Label Patient Package Insert Review

Identifiers

Application: NDA 21065
Drugs@FDA: Overview at FDA
Company: APIL

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