NDA 021835

GALDERMA LABS LP

FDA Drug Application

Application #021835

Documents

• Letter: 2011-01-14
• Label: 2005-11-01
• Label: 2012-09-11
• Label: 2012-08-20
• Review: 2007-07-03
• Letter: 2005-11-01
• Letter: 2011-01-14
• Letter: 2012-09-10
• Letter: 2012-08-20
• Label: 2011-01-14
• Label: 2011-01-14
• Label: 2018-12-26
• Letter: 2018-12-31

Application Sponsors

NDA 021835

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

SPRAY;TOPICAL

0.05%

1

CLOBEX

CLOBETASOL PROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2005-10-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2011-01-12	N/A
LABELING; Labeling	SUPPL	4	AP	2011-01-12	STANDARD
LABELING; Labeling	SUPPL	6	AP	2012-09-07	UNKNOWN
LABELING; Labeling	SUPPL	7	AP	2012-08-17	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-05-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-04-15	STANDARD
LABELING; Labeling	SUPPL	15	AP	2018-12-21	STANDARD

Submissions Property Types

SUPPL	2	Null	6
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	15	Null	15

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21835
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)