NDA 019778

MERCK

FDA Drug Application

Application #019778

Documents

• Letter: 2002-07-02
• Letter: 2005-10-11
• Letter: 2007-02-12
• Letter: 2008-10-14
• Letter: 2008-10-14
• Label: 2011-02-11
• Label: 2013-03-01
• Letter: 1998-10-28
• Letter: 2002-11-08
• Letter: 2004-03-03
• Letter: 2006-06-20
• Letter: 2006-10-23
• Letter: 2011-06-17
• Letter: 2011-11-21
• Letter: 2011-08-31
• Letter: 2012-06-08
• Letter: 2013-02-28
• Review: 1998-10-28
• Label: 1998-10-28
• Label: 2011-11-21
• Label: 2011-08-30
• Label: 2012-06-11
• Review: 2001-06-22
• Review: 2004-04-21

Application Sponsors

NDA 019778

MERCK

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	12.5MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
002	TABLET;ORAL	25MG;20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL
003	TABLET;ORAL	12.5MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PRINZIDE	HYDROCHLOROTHIAZIDE; LISINOPRIL

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1989-02-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1989-10-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	1990-04-12	STANDARD
LABELING; Labeling	SUPPL	4	AP	1991-02-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	1991-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-09-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1992-01-23	STANDARD
LABELING; Labeling	SUPPL	9	AP	1992-05-07	STANDARD
LABELING; Labeling	SUPPL	10	AP	1992-05-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	1992-09-30	STANDARD
LABELING; Labeling	SUPPL	12	AP	1996-09-03	STANDARD
LABELING; Labeling	SUPPL	13	AP	1993-03-10	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	1993-11-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	1994-01-14	STANDARD
LABELING; Labeling	SUPPL	16	AP	1994-05-11	STANDARD
LABELING; Labeling	SUPPL	17	AP	1993-09-23	STANDARD
LABELING; Labeling	SUPPL	18	AP	1994-03-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	1994-07-24	STANDARD
LABELING; Labeling	SUPPL	21	AP	1995-05-30	STANDARD
LABELING; Labeling	SUPPL	22	AP	1995-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1995-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-06-08	STANDARD
LABELING; Labeling	SUPPL	25	AP	1995-09-28	STANDARD
LABELING; Labeling	SUPPL	26	AP	1995-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1995-11-01	STANDARD
LABELING; Labeling	SUPPL	28	AP	1998-10-28	STANDARD
LABELING; Labeling	SUPPL	29	AP	1999-02-17	STANDARD
LABELING; Labeling	SUPPL	30	AP	2001-08-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-06-09	STANDARD
LABELING; Labeling	SUPPL	32	AP	2002-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2001-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-07-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2004-03-02	STANDARD
LABELING; Labeling	SUPPL	36	AP	2005-10-05	STANDARD
LABELING; Labeling	SUPPL	37	AP	2006-06-16	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-10-18	STANDARD
LABELING; Labeling	SUPPL	40	AP	2007-02-02	STANDARD
LABELING; Labeling	SUPPL	42	AP	2008-10-09	STANDARD
LABELING; Labeling	SUPPL	43	AP	2008-10-09	STANDARD
LABELING; Labeling	SUPPL	44	AP	2011-06-10	STANDARD
LABELING; Labeling	SUPPL	45	AP	2011-01-28	STANDARD
LABELING; Labeling	SUPPL	46	AP	2011-11-17	STANDARD
LABELING; Labeling	SUPPL	47	AP	2011-08-26	STANDARD
LABELING; Labeling	SUPPL	48	AP	2012-06-06	STANDARD
LABELING; Labeling	SUPPL	49	AP	2013-02-26	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	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	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19778
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)