NDA 021592

NOVARTIS

FDA Drug Application

Application #021592

Documents

• Letter: 2010-06-03
• Label: 2010-06-02
• Review: 2008-11-25
• Medication Guide: 2007-02-20
• Letter: 2006-12-28
• Label: 2006-12-26

Application Sponsors

NDA 021592

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

POWDER;INHALATION

0.0085MG/INH

0

FORADIL CERTIHALER

FORMOTEROL FUMARATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-12-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-06-02	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21592
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)