NDA 021129

PARKE DAVIS

FDA Drug Application

Application #021129

Documents

• Letter: 2004-06-10
• Letter: 2006-05-05
• Letter: 2011-03-07
• Letter: 2011-08-12
• Letter: 2013-05-07
• Letter: 2013-05-07
• Letter: 2014-08-20
• Letter: 2015-09-17
• Letter: 2015-04-22
• Label: 2005-02-23
• Label: 2009-04-28
• Label: 2010-10-11
• Label: 2013-05-09
• Label: 2014-08-20
• Label: 2015-09-23
• Review: 2004-05-06
• Letter: 2002-01-30
• Letter: 2005-02-23
• Letter: 2009-05-01
• Letter: 2010-10-13
• Letter: 2013-05-07
• Label: 2011-03-04
• Label: 2011-08-11
• Label: 2013-05-09
• Label: 2013-05-09
• Label: 2015-04-27
• Review: 2004-05-06
• Other Important Information from FDA: 2008-02-01
• Label: 2017-03-27
• Medication Guide: 2017-03-27
• Letter: 2017-03-29
• Letter: 2017-10-19
• Label: 2017-10-20
• Letter: 2020-04-03
• Label: 2020-04-10
• Letter: 2020-12-21
• Label: 2020-12-21
• Medication Guide: 2020-12-21

Application Sponsors

NDA 021129

PARKE DAVIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

250MG/5ML

1

NEURONTIN

GABAPENTIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2000-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-09-19	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2000-10-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2002-01-18	STANDARD
LABELING; Labeling	SUPPL	9	AP	2002-01-30	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2002-08-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-12-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	2005-02-18	STANDARD
LABELING; Labeling	SUPPL	20	AP	2006-05-03	STANDARD
LABELING; Labeling	SUPPL	22	AP	2011-03-01	STANDARD
LABELING; Labeling	SUPPL	27	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	29	AP	2010-10-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2011-08-10	UNKNOWN
LABELING; Labeling	SUPPL	35	AP	2013-05-01	STANDARD
LABELING; Labeling	SUPPL	36	AP	2013-05-01	UNKNOWN
LABELING; Labeling	SUPPL	37	AP	2013-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2013-07-18	STANDARD
LABELING; Labeling	SUPPL	39	AP	2014-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2014-04-15	STANDARD
LABELING; Labeling	SUPPL	42	AP	2015-09-14	STANDARD
LABELING; Labeling	SUPPL	43	AP	2015-04-21	STANDARD
LABELING; Labeling	SUPPL	44	AP	2017-03-24	STANDARD
LABELING; Labeling	SUPPL	46	AP	2017-10-18	STANDARD
LABELING; Labeling	SUPPL	49	AP	2020-04-02	901 REQUIRED
LABELING; Labeling	SUPPL	50	AP	2020-12-16	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	6
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	22	Null	7
SUPPL	29	Null	7
SUPPL	33	Null	15
SUPPL	35	Null	15
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	0
SUPPL	39	Null	15
SUPPL	41	Null	0
SUPPL	42	Null	6
SUPPL	43	Null	7
SUPPL	44	Null	7
SUPPL	46	Null	7
SUPPL	49	Null	6
SUPPL	50	Null	6

TE Codes

001

Prescription

AA

CDER Filings

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