Foradil Certihaler

NDA 21592, held by Novartis. Formoterol Fumarate.

As of Nov 14, 2026, NDA 21592 (Foradil Certihaler), held by Novartis, was first approved by FDA on Dec 15, 2006, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 15, 2006
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 15, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Foradil Certihaler0.0085MG/INH · powder;inhalation	Formoterol Fumarate	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 2, 2010	Supplement 3Labeling · Standard review	Approved	Letter Label
Dec 15, 2006	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21592
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