NDA 020748

GALDERMA LABS LP

FDA Drug Application

Application #020748

Documents

• Review: 2003-05-08
• Letter: 2000-05-26
• Label: 2000-05-26

Application Sponsors

NDA 020748

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.1%

1

DIFFERIN

ADAPALENE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-05-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2013-02-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2014-08-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20748
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)