NDA 010596

PARKE DAVIS

FDA Drug Application

Application #010596

Documents

• Letter: 2001-04-09
• Letter: 2001-04-09
• Letter: 2002-04-17
• Label: 2010-10-11
• Letter: 2009-04-29
• Letter: 2010-10-13
• Letter: 2011-06-17
• Medication Guide: 2010-10-13
• Label: 2009-04-28

Application Sponsors

NDA 010596

PARKE DAVIS

Marketing Status

• Discontinued: 007
• Prescription: 008

Application Products

007	CAPSULE;ORAL	150MG	1	CELONTIN	METHSUXIMIDE
008	CAPSULE;ORAL	300MG	1	CELONTIN	METHSUXIMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1957-02-08	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1977-05-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1981-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1987-08-20	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2001-04-09
LABELING; Labeling	SUPPL	10	AP	1990-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-12-11	PRIORITY
LABELING; Labeling	SUPPL	12	AP	2001-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-10-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-04-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-04-11	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2002-04-17	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	22	AP	2010-10-11	STANDARD
REMS; REMS	SUPPL	23	AP	2011-06-15	N/A

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	22	Null	7
SUPPL	23	Null	6

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10596
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)