NDA 021400

BAYER HLTHCARE

FDA Drug Application

Application #021400

Documents

• Letter: 2003-08-28
• Letter: 2005-07-15
• Letter: 2007-04-20
• Letter: 2007-10-22
• Letter: 2008-03-21
• Letter: 2008-05-21
• Label: 2005-05-17
• Label: 2007-04-09
• Label: 2008-03-20
• Label: 2011-11-30
• Label: 2013-08-06
• Label: 2014-05-02
• Label: 2015-09-23
• Review: 2003-10-29
• Letter: 2005-05-17
• Letter: 2011-11-28
• Letter: 2013-08-05
• Letter: 2014-04-30
• Letter: 2015-09-17
• Label: 2003-08-28
• Label: 2005-07-08
• Label: 2007-10-18
• Other Important Information from FDA: 2007-10-18
• Label: 2017-08-17
• Letter: 2017-08-29

Application Sponsors

NDA 021400

BAYER HLTHCARE

Marketing Status

• Prescription: 001
• Prescription: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	1	LEVITRA	VARDENAFIL HYDROCHLORIDE
002	TABLET;ORAL	10MG	1	LEVITRA	VARDENAFIL HYDROCHLORIDE
003	TABLET;ORAL	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	LEVITRA	VARDENAFIL HYDROCHLORIDE
004	TABLET;ORAL	20MG	1	LEVITRA	VARDENAFIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2003-08-19	STANDARD
LABELING; Labeling	SUPPL	2	AP	2005-05-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2005-07-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2007-04-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2007-10-18	STANDARD
LABELING; Labeling	SUPPL	11	AP	2008-03-19	STANDARD
LABELING; Labeling	SUPPL	12	AP	2008-05-15	STANDARD
LABELING; Labeling	SUPPL	13	AP	2011-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	16	AP	2013-08-02	STANDARD
LABELING; Labeling	SUPPL	17	AP	2014-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2014-11-03	STANDARD
LABELING; Labeling	SUPPL	19	AP	2015-09-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2017-08-16	STANDARD

Submissions Property Types

SUPPL	13	Null	7
SUPPL	16	Null	6
SUPPL	17	Null	7
SUPPL	18	Null	0
SUPPL	19	Null	15
SUPPL	20	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB

CDER Filings

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            [products] => []
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        )

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