NDA 021415

GALDERMA LABS LP

FDA Drug Application

Application #021415

Documents

• Letter: 2005-06-07
• Label: 2005-06-07
• Review: 2006-03-21
• Letter: 2004-07-30
• Letter: 2008-06-30
• Letter: 2012-11-23
• Label: 2004-07-30
• Label: 2008-06-30
• Label: 2012-11-28

Application Sponsors

NDA 021415

GALDERMA LABS LP

Marketing Status

• Discontinued: 001

Application Products

001

CREAM;TOPICAL

EQ 16.8% BASE

0

METVIXIA

METHYL AMINOLEVULINATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-07-27	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2008-06-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2012-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21415
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)