NDA 050805

GALDERMA LABS LP

FDA Drug Application

Application #050805

Documents

• Letter: 2006-05-30
• Letter: 2012-11-08
• Letter: 2013-07-29
• Letter: 2010-05-17
• Label: 2006-05-30
• Label: 2010-05-17
• Label: 2012-11-08
• Label: 2013-07-30
• Review: 2008-02-22
• Label: 2021-12-17
• Letter: 2021-12-21

Application Sponsors

NDA 050805

GALDERMA LABS LP

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

40MG

1

ORACEA

DOXYCYCLINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2006-05-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	2010-05-13	STANDARD
LABELING; Labeling	SUPPL	7	AP	2012-11-07	STANDARD
LABELING; Labeling	SUPPL	8	AP	2013-07-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-09-03	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-12-15	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50805
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)