NDA 012380

PARKE DAVIS

FDA Drug Application

Application #012380

Documents

• Letter: 2001-04-09
• Letter: 2006-09-18
• Letter: 2010-09-20
• Letter: 2011-06-17
• Letter: 2012-05-09
• Letter: 2016-05-20
• Label: 2010-09-20
• Label: 2012-05-07
• Letter: 2001-04-09
• Letter: 2001-04-09
• Letter: 2002-04-19
• Letter: 2009-04-29
• Label: 2009-04-28
• Label: 2016-05-20
• Medication Guide: 2012-05-07
• Letter: 2021-10-29
• Label: 2021-10-29

Application Sponsors

NDA 012380

PARKE DAVIS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

1

ZARONTIN

ETHOSUXIMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1960-11-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-06-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1980-12-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1981-02-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1981-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1981-05-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1981-12-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1982-09-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-11-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1984-07-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1991-01-08	PRIORITY
LABELING; Labeling	SUPPL	22	AP	2001-04-09
LABELING; Labeling	SUPPL	23	AP	2001-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-02-22	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2001-04-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-06-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2000-09-22	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2002-04-19	STANDARD
LABELING; Labeling	SUPPL	30	AP	2006-09-01	STANDARD
LABELING; Labeling	SUPPL	31	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	32	AP	2010-09-14	STANDARD
REMS; REMS	SUPPL	33	AP	2011-06-15	N/A
LABELING; Labeling	SUPPL	34	AP	2012-05-03	UNKNOWN
LABELING; Labeling	SUPPL	36	AP	2016-05-17	STANDARD
LABELING; Labeling	SUPPL	37	AP	2021-10-28	STANDARD

Submissions Property Types

SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	32	Null	6
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	36	Null	15
SUPPL	37	Null	6

TE Codes

001

Prescription

AB

CDER Filings

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