NDA 021753

GALDERMA LABS LP

FDA Drug Application

Application #021753

Documents

• Letter: 2007-07-05
• Label: 2007-06-27
• Label: 2012-02-27
• Letter: 2010-09-07
• Letter: 2014-06-18
• Label: 2010-09-07
• Review: 2008-03-14
• Letter: 2022-08-26
• Label: 2022-08-29

Application Sponsors

NDA 021753

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.3%

1

DIFFERIN

ADAPALENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-06-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-09-01	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2012-02-27	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-06-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-08-25	STANDARD

Submissions Property Types

SUPPL	2	Null	6
SUPPL	4	Null	15
SUPPL	7	Null	0
SUPPL	11	Null	6

TE Codes

001

Prescription

AB

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21753
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)