ANDA 071425

GALDERMA LABS LP

FDA Drug Application

Application #071425

Application Sponsors

ANDA 071425

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

0.05%

0

DESOWEN

DESONIDE

FDA Submissions

	ORIG	1	AP	1988-06-15
LABELING; Labeling	SUPPL	2	AP	1991-11-06
LABELING; Labeling	SUPPL	3	AP	1992-10-30
LABELING; Labeling	SUPPL	4	AP	1993-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-11-01
LABELING; Labeling	SUPPL	6	AP	1997-01-31

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0

TE Codes

001

Prescription

AB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71425
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)