NDA 019048

GALDERMA LABS LP

FDA Drug Application

Application #019048

Application Sponsors

NDA 019048

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

DESOWEN

DESONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1984-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-10-25	STANDARD
LABELING; Labeling	SUPPL	4	AP	1988-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1989-08-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-08-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	1991-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-08-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-01-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	1995-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2013-03-13	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19048
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)