NDA 018144

PARKE DAVIS

FDA Drug Application

Application #018144

Application Sponsors

NDA 018144

PARKE DAVIS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	CAPSULE;ORAL	5MG	0	CENTRAX	PRAZEPAM
002	CAPSULE;ORAL	10MG	0	CENTRAX	PRAZEPAM
003	CAPSULE;ORAL	20MG	0	CENTRAX	PRAZEPAM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1979-11-30	STANDARD
LABELING; Labeling	SUPPL	8	AP	1984-05-01
LABELING; Labeling	SUPPL	9	AP	1996-04-26
LABELING; Labeling	SUPPL	11	AP	1996-04-26
LABELING; Labeling	SUPPL	13	AP	1996-04-26
LABELING; Labeling	SUPPL	15	AP	1996-04-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	1996-04-26	STANDARD

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18144
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)