NDA 018006

PARKE DAVIS

FDA Drug Application

Application #018006

Application Sponsors

NDA 018006

PARKE DAVIS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	EQ 50MG BASE	0	MECLOMEN	MECLOFENAMATE SODIUM
002	CAPSULE;ORAL	EQ 100MG BASE	0	MECLOMEN	MECLOFENAMATE SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1980-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1981-04-11	STANDARD
LABELING; Labeling	SUPPL	3	AP	1981-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-04-09	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	1988-08-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-05-15	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	1990-07-23
LABELING; Labeling	SUPPL	12	AP	1985-11-20
EFFICACY; Efficacy	SUPPL	13	AP	1990-07-23
LABELING; Labeling	SUPPL	14	AP	1987-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-06-07	STANDARD
LABELING; Labeling	SUPPL	18	AP	1989-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1990-05-14	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18006
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)