Foradil

NDA 20831, held by Novartis. Formoterol Fumarate.

As of Nov 14, 2026, NDA 20831 (Foradil), held by Novartis, was first approved by FDA on Feb 16, 2001, with 18 approved supplements and 0 published complete response letters.

First approved: Feb 16, 2001
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Jun 27, 2003	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 16, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Foradil0.012MG/INH Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · powder;inhalation	Formoterol Fumarate	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Mar 2, 2016	Supplement 34Manufacturing · Standard review	Approved	None posted
Dec 13, 2013	Supplement 33Manufacturing · Standard review	Approved	None posted
Apr 17, 2013	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 29, 2013	Supplement 32REMS	Approved	Letter
Mar 29, 2013	Supplement 29Labeling · Standard review	Approved	Letter
Feb 8, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Sep 27, 2012	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 20, 2012	Supplement 27Labeling · Standard review	Approved	Letter Label
May 18, 2011	Supplement 22REMS	Approved	Letter
May 3, 2011	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 9, 2011	Supplement 24Labeling	Approved	Letter
Jun 2, 2010	Supplement 21Labeling	Approved	Letter Label
Jun 19, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Jun 27, 2003	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 17, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 21, 2001	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 25, 2001	Supplement 2Labeling · Standard review	Approved	Review Letter Label
Apr 25, 2001	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 16, 2001	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20831
Drugs@FDA: Overview at FDA
Company: Novartis Pharmaceuticals Corporation

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