NDA 010151

PARKE DAVIS

FDA Drug Application

Application #010151

Documents

• Letter: 2001-11-20
• Letter: 2001-11-20
• Letter: 2001-11-20
• Letter: 2001-11-20
• Letter: 2013-03-08
• Letter: 2014-01-28
• Letter: 2015-04-17
• Letter: 2016-01-26
• Label: 2011-11-16
• Label: 2013-03-08
• Label: 2014-04-04
• Label: 2016-01-26
• Label: 2016-06-21
• Letter: 2001-11-20
• Letter: 2001-11-20
• Letter: 2011-11-21
• Letter: 2014-04-04
• Review: 2007-07-06
• Review: 2007-07-06
• Review: 2007-07-06
• Review: 2007-07-06
• Label: 2014-01-28
• Label: 2015-04-16
• Review: 2007-07-06
• Review: 2007-07-06
• Letter: 2016-12-06
• Letter: 2016-12-06
• Label: 2017-08-17
• Letter: 2017-08-29
• Label: 2017-11-01
• Label: 2017-11-01

Application Sponsors

NDA 010151

PARKE DAVIS

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

DILANTIN

PHENYTOIN SODIUM

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1956-03-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	1975-12-05
LABELING; Labeling	SUPPL	11	AP	1978-01-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1977-01-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	1978-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1981-06-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	1981-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1983-06-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	2001-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1983-08-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1986-05-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1986-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1986-09-30	STANDARD
LABELING; Labeling	SUPPL	29	AP	2001-11-20
LABELING; Labeling	SUPPL	30	AP	2001-11-20
LABELING; Labeling	SUPPL	31	AP	1995-11-22	STANDARD
LABELING; Labeling	SUPPL	32	AP	2001-11-20	STANDARD
LABELING; Labeling	SUPPL	33	AP	2001-11-20	STANDARD
LABELING; Labeling	SUPPL	34	AP	2001-11-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1997-05-30	STANDARD
LABELING; Labeling	SUPPL	36	AP	2011-11-13	STANDARD
LABELING; Labeling	SUPPL	37	AP	2013-03-06	STANDARD
LABELING; Labeling	SUPPL	38	AP	2014-01-24	STANDARD
LABELING; Labeling	SUPPL	39	AP	2014-04-03	STANDARD
LABELING; Labeling	SUPPL	40	AP	2015-04-15	STANDARD
LABELING; Labeling	SUPPL	41	AP	2016-01-25	STANDARD
LABELING; Labeling	SUPPL	42	AP	2016-06-16	STANDARD
LABELING; Labeling	SUPPL	44	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	45	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	46	AP	2017-08-15	STANDARD
LABELING; Labeling	SUPPL	47	AP	2017-10-31	STANDARD
LABELING; Labeling	SUPPL	48	AP	2017-10-31	STANDARD

Submissions Property Types

SUPPL	13	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	15
SUPPL	37	Null	15
SUPPL	38	Null	6
SUPPL	39	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	15
SUPPL	42	Null	6
SUPPL	44	Null	15
SUPPL	45	Null	6
SUPPL	46	Null	6
SUPPL	47	Null	7
SUPPL	48	Null	7

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10151
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)