NDA 020338

GALDERMA LABS LP

FDA Drug Application

Application #020338

Documents

• Review: 2019-02-15

Application Sponsors

NDA 020338

GALDERMA LABS LP

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;TOPICAL

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

DIFFERIN

ADAPALENE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-04-08	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20338
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)