NDA 020001

GALDERMA LABS LP

FDA Drug Application

Application #020001

Documents

• Letter: 2015-12-18

Application Sponsors

NDA 020001

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

0.01%

1

CAPEX

FLUOCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-08-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-11-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	1995-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1997-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2001-01-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-07-06	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-12-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2016-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2016-03-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	15
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 20001
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)