NDA 018714

BAYER HLTHCARE

FDA Drug Application

Application #018714

Documents

• Letter: 2004-07-21
• Label: 2004-07-21
• Label: 2010-08-01
• Label: 2014-03-05
• Letter: 2004-07-21
• Letter: 2010-08-20
• Letter: 2014-02-27
• Label: 2004-07-21
• Label: 2019-01-09
• Letter: 2019-01-23

Application Sponsors

NDA 018714

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

600MG

1

BILTRICIDE

PRAZIQUANTEL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1982-12-29	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1985-08-20
LABELING; Labeling	SUPPL	3	AP	1988-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1988-08-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-08-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1989-11-07	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	9	AP	2004-07-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2010-08-16	STANDARD
LABELING; Labeling	SUPPL	13	AP	2014-02-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2014-09-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2014-11-20	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2019-01-08	STANDARD

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	7

TE Codes

001

Prescription

AB

CDER Filings

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    [0] => Array
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            [ApplNo] => 18714
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)