NDA 021112

GALDERMA LABS LP

FDA Drug Application

Application #021112

Documents

• Letter: 2012-12-26
• Letter: 2013-01-28
• Label: 2002-01-18
• Label: 2014-04-01
• Letter: 2014-04-02
• Label: 2013-01-22
• Review: 2002-03-26

Application Sponsors

NDA 021112

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.01%;4%;0.05%

1

TRI-LUMA

FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2002-01-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2013-01-16	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2013-07-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2014-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-01-20	STANDARD

Submissions Property Types

SUPPL	6	Null	6
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	6
SUPPL	10	Null	0
SUPPL	11	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21112
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)