NDA 019558

MERCK

FDA Drug Application

Application #019558

Documents

• Letter: 2004-06-14
• Letter: 2003-06-08
• Letter: 2005-10-11
• Letter: 2006-10-23
• Letter: 2007-02-12
• Letter: 2008-10-14
• Letter: 2011-06-17
• Letter: 2012-06-08
• Letter: 2013-02-28
• Letter: 2015-07-13
• Label: 2004-06-14
• Label: 2003-06-08
• Label: 2011-11-21
• Label: 2012-06-11
• Label: 2013-03-01
• Label: 2015-07-13
• Letter: 2004-05-07
• Letter: 2004-03-03
• Letter: 2006-06-20
• Letter: 2008-10-14
• Letter: 2011-11-21
• Letter: 2015-09-01
• Review: 2001-06-22
• Review: 2005-04-17
• Label: 2015-09-03
• Other Important Information from FDA: 2006-06-09
• Letter: 2016-10-19
• Label: 2016-10-17
• Label: 2017-09-20
• Letter: 2017-09-22
• Label: 2018-10-15
• Letter: 2018-10-17
• Label: 2021-11-10
• Letter: 2021-11-10

Application Sponsors

NDA 019558

MERCK

Marketing Status

• Prescription: 001
• Discontinued: 002
• Discontinued: 003
• Prescription: 004
• Discontinued: 006

Application Products

001	TABLET;ORAL	5MG	0	PRINIVIL	LISINOPRIL
002	TABLET;ORAL	10MG	0	PRINIVIL	LISINOPRIL
003	TABLET;ORAL	20MG	0	PRINIVIL	LISINOPRIL
004	TABLET;ORAL	40MG	0	PRINIVIL	LISINOPRIL
006	TABLET;ORAL	2.5MG	0	PRINIVIL	LISINOPRIL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-12-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	1988-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-08-19	STANDARD
LABELING; Labeling	SUPPL	4	AP	1989-03-29
LABELING; Labeling	SUPPL	5	AP	1989-01-31
LABELING; Labeling	SUPPL	6	AP	1989-08-09
EFFICACY; Efficacy	SUPPL	7	AP	1993-06-14
LABELING; Labeling	SUPPL	8	AP	1990-04-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-01-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	1991-02-06
LABELING; Labeling	SUPPL	11	AP	1991-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1992-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-01-23	STANDARD
LABELING; Labeling	SUPPL	16	AP	1992-05-07
LABELING; Labeling	SUPPL	17	AP	1992-05-13
LABELING; Labeling	SUPPL	18	AP	1992-09-30
LABELING; Labeling	SUPPL	19	AP	1996-09-03	STANDARD
LABELING; Labeling	SUPPL	20	AP	1993-03-10	STANDARD
LABELING; Labeling	SUPPL	21	AP	1994-01-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	1994-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1994-01-28	STANDARD
LABELING; Labeling	SUPPL	24	AP	1993-09-23	STANDARD
LABELING; Labeling	SUPPL	25	AP	1994-03-10	STANDARD
LABELING; Labeling	SUPPL	26	AP	1994-07-24	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	1995-11-24	STANDARD
LABELING; Labeling	SUPPL	28	AP	1995-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1995-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-06-08	STANDARD
LABELING; Labeling	SUPPL	31	AP	1995-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1995-06-26	STANDARD
LABELING; Labeling	SUPPL	33	AP	1995-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1995-11-01	STANDARD
LABELING; Labeling	SUPPL	35	AP	1996-09-03	STANDARD
LABELING; Labeling	SUPPL	36	AP	1999-02-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1999-03-15	STANDARD
LABELING; Labeling	SUPPL	38	AP	2001-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2000-06-09	STANDARD
LABELING; Labeling	SUPPL	40	AP	2004-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2001-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2001-08-23	STANDARD
EFFICACY; Efficacy	SUPPL	43	AP	2003-05-29	STANDARD
LABELING; Labeling	SUPPL	44	AP	2004-03-02	STANDARD
LABELING; Labeling	SUPPL	46	AP	2005-10-05	STANDARD
LABELING; Labeling	SUPPL	47	AP	2006-06-16	STANDARD
LABELING; Labeling	SUPPL	49	AP	2006-10-18	STANDARD
LABELING; Labeling	SUPPL	50	AP	2007-02-02	STANDARD
LABELING; Labeling	SUPPL	51	AP	2008-10-09	STANDARD
LABELING; Labeling	SUPPL	52	AP	2008-10-09	STANDARD
LABELING; Labeling	SUPPL	53	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	54	AP	2011-11-17	UNKNOWN
LABELING; Labeling	SUPPL	55	AP	2012-06-07	UNKNOWN
LABELING; Labeling	SUPPL	56	AP	2013-02-26	STANDARD
LABELING; Labeling	SUPPL	57	AP	2015-07-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	2014-08-22	STANDARD
LABELING; Labeling	SUPPL	59	AP	2015-08-28	STANDARD
LABELING; Labeling	SUPPL	60	AP	2016-10-14	STANDARD
LABELING; Labeling	SUPPL	61	AP	2017-09-19	STANDARD
LABELING; Labeling	SUPPL	62	AP	2018-10-12	STANDARD
LABELING; Labeling	SUPPL	63	AP	2021-11-09	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	23	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	8
SUPPL	53	Null	6
SUPPL	54	Null	7
SUPPL	55	Null	7
SUPPL	56	Null	15
SUPPL	57	Null	6
SUPPL	58	Null	0
SUPPL	59	Null	15
SUPPL	60	Null	6
SUPPL	61	Null	6
SUPPL	62	Null	7
SUPPL	63	Null	7

TE Codes

001	Prescription	AB
004	Prescription	AB

CDER Filings

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    [0] => Array
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            [ApplNo] => 19558
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)