NDA 019851

US PHARMS HOLDINGS I

FDA Drug Application

Application #019851

Documents

• Letter: 2004-03-03
• Letter: 2003-11-05
• Letter: 2007-02-12
• Letter: 2008-06-02
• Letter: 2010-01-07
• Letter: 2011-06-16
• Letter: 2015-07-23
• Label: 2004-04-05
• Label: 2011-06-16
• Label: 2015-07-24
• Letter: 2009-01-26
• Letter: 2012-05-21
• Letter: 2012-02-06
• Letter: 2014-12-15
• Letter: 2015-01-27
• Letter: 2015-07-23
• Label: 2009-11-16
• Label: 2012-05-22
• Label: 2012-01-23
• Label: 2012-09-25
• Label: 2014-12-16
• Label: 2015-01-30
• Label: 2015-07-24
• Other Important Information from FDA: 2006-06-09
• Label: 2017-08-07
• Letter: 2017-08-07
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-01-09
• Letter: 2019-02-04

Application Sponsors

NDA 019851

US PHARMS HOLDINGS I

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	1	LOTENSIN	BENAZEPRIL HYDROCHLORIDE
002	TABLET;ORAL	10MG	1	LOTENSIN	BENAZEPRIL HYDROCHLORIDE
003	TABLET;ORAL	20MG	1	LOTENSIN	BENAZEPRIL HYDROCHLORIDE
004	TABLET;ORAL	40MG	1	LOTENSIN	BENAZEPRIL HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-03-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	1992-06-25
LABELING; Labeling	SUPPL	4	AP	1992-11-20	STANDARD
LABELING; Labeling	SUPPL	5	AP	1993-10-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-03-15	STANDARD
LABELING; Labeling	SUPPL	7	AP	1995-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-02-08	STANDARD
LABELING; Labeling	SUPPL	9	AP	1995-11-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-07-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-11-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1996-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1997-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-08-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	1998-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-07-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-04-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-11-02	STANDARD
LABELING; Labeling	SUPPL	21	AP	2001-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2001-08-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2001-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-04-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-09-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2002-10-25	STANDARD
EFFICACY; Efficacy	SUPPL	28	AP	2004-03-02	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2003-10-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2007-02-02	STANDARD
LABELING; Labeling	SUPPL	36	AP	2008-05-29	STANDARD
LABELING; Labeling	SUPPL	37	AP	2009-01-22	STANDARD
LABELING; Labeling	SUPPL	38	AP	2009-11-10	STANDARD
LABELING; Labeling	SUPPL	40	AP	2011-06-14	UNKNOWN
LABELING; Labeling	SUPPL	42	AP	2012-05-17	UNKNOWN
LABELING; Labeling	SUPPL	43	AP	2012-01-19	UNKNOWN
LABELING; Labeling	SUPPL	44	AP	2012-09-21	UNKNOWN
LABELING; Labeling	SUPPL	45	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	46	AP	2014-12-12	STANDARD
LABELING; Labeling	SUPPL	47	AP	2015-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	2015-07-14	STANDARD
LABELING; Labeling	SUPPL	49	AP	2015-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2015-12-17	STANDARD
LABELING; Labeling	SUPPL	52	AP	2017-08-03	STANDARD
LABELING; Labeling	SUPPL	54	AP	2019-01-07	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	8
SUPPL	38	Null	6
SUPPL	40	Null	6
SUPPL	42	Null	15
SUPPL	43	Null	15
SUPPL	44	Null	6
SUPPL	45	Null	6
SUPPL	46	Null	7
SUPPL	47	Null	15
SUPPL	48	Null	0
SUPPL	49	Null	6
SUPPL	50	Null	0
SUPPL	52	Null	15
SUPPL	54	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

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            [ApplNo] => 19851
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)