NDA 050783

GALDERMA LABS LP

FDA Drug Application

Application #050783

Documents

• Letter: 2001-02-02
• Letter: 2004-04-07
• Label: 2001-02-02
• Review: 2001-02-02
• Label: 2004-04-05

Application Sponsors

NDA 050783

GALDERMA LABS LP

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

PERIOSTAT

DOXYCYCLINE HYCLATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2001-02-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2004-03-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	9

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50783
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)