NDA 016768

PARKE DAVIS

FDA Drug Application

Application #016768

Application Sponsors

NDA 016768

PARKE DAVIS

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET;ORAL	0.1MG	0	ESTROVIS	QUINESTROL
003	TABLET;ORAL	0.2MG	0	ESTROVIS	QUINESTROL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-04-26	STANDARD
LABELING; Labeling	SUPPL	2	AP	1996-04-26
EFFICACY; Efficacy	SUPPL	4	AP	1996-04-26
EFFICACY; Efficacy	SUPPL	5	AP	1996-04-26
EFFICACY; Efficacy	SUPPL	6	AP	1996-04-26
LABELING; Labeling	SUPPL	9	AP	1996-04-26
LABELING; Labeling	SUPPL	10	AP	1996-04-26

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16768
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)