ANDA 080258

PARKE-DAVIS

FDA Drug Application

Application #080258

Documents

• Label: 2009-10-19
• Label: 2014-01-22
• Label: 2014-01-22

Application Sponsors

ANDA 080258

PARKE-DAVIS

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

250MG/5ML

0

ZARONTIN

ETHOSUXIMIDE

FDA Submissions

	ORIG	1	AP	1974-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-10-27
LABELING; Labeling	SUPPL	20	AP	2006-10-03
LABELING; Labeling	SUPPL	25	AP	2009-05-06
LABELING; Labeling	SUPPL	26	AP	2009-11-20
LABELING; Labeling	SUPPL	27	AP	2009-11-20
REMS; REMS	SUPPL	28	AP	2011-04-25
LABELING; Labeling	SUPPL	29	AP	2014-01-16	STANDARD
REMS; REMS	SUPPL	30	AP	2012-10-25
LABELING; Labeling	SUPPL	31	AP	2014-01-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2021-10-29	STANDARD
LABELING; Labeling	SUPPL	35	AP	2021-10-29	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	25	Null	7
SUPPL	26	Null	7
SUPPL	27	Null	7
SUPPL	29	Null	15
SUPPL	30	Null	17
SUPPL	31	Null	31
SUPPL	32	Null	7
SUPPL	35	Null	7

TE Codes

001

Prescription

AA

CDER Filings

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            [ApplNo] => 80258
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)