ANDA 072354

GALDERMA LABS LP

FDA Drug Application

Application #072354

Documents

• Review: 2012-01-27

Application Sponsors

ANDA 072354

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

0

DESOWEN

DESONIDE

FDA Submissions

	ORIG	1	AP	1992-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1995-07-28
LABELING; Labeling	SUPPL	4	AP	1995-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-06-12
LABELING; Labeling	SUPPL	6	AP	1998-06-12
LABELING; Labeling	SUPPL	9	AP	2015-04-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	15

TE Codes

001

Prescription

AB

CDER Filings

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            [companyName] => 
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)