NDA 021535

GALDERMA LABS LP

FDA Drug Application

Application #021535

Documents

• Letter: 2012-12-03
• Label: 2003-07-28
• Label: 2012-08-20
• Label: 2014-01-14
• Review: 2004-06-14
• Letter: 2003-07-28
• Letter: 2012-08-20

Application Sponsors

NDA 021535

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

LOTION;TOPICAL

0.05%

1

CLOBEX

CLOBETASOL PROPIONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2003-07-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2012-08-17	UNKNOWN
LABELING; Labeling	SUPPL	3	AP	2012-11-30	UNKNOWN

Submissions Property Types

ORIG	1	Null	31
SUPPL	2	Null	6
SUPPL	3	Null	6

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21535
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)