NDA 019643

MERCK

FDA Drug Application

Application #019643

Documents

• Letter: 2007-04-25
• Letter: 2002-09-20
• Letter: 2005-11-18
• Letter: 2008-01-09
• Letter: 2010-07-02
• Letter: 2011-02-07
• Letter: 2012-11-05
• Letter: 2014-02-28
• Label: 2007-04-20
• Label: 2003-04-16
• Label: 2005-04-12
• Label: 2005-11-08
• Label: 2011-02-04
• Label: 2012-02-28
• Label: 2012-11-06
• Letter: 1999-03-11
• Letter: 2002-02-14
• Letter: 2005-04-12
• Letter: 2005-06-14
• Letter: 2007-06-04
• Letter: 2009-03-11
• Letter: 2011-06-17
• Letter: 2012-02-28
• Letter: 2012-11-05
• Review: 2007-07-06
• Review: 1997-06-25
• Review: 2001-08-17
• Review: 2007-07-06
• Other: 2012-02-28
• Label: 2002-02-14
• Label: 2003-04-17
• Label: 2002-09-20
• Label: 2005-06-14
• Label: 2007-06-04
• Label: 2009-03-17
• Label: 2010-07-06
• Label: 2012-11-06
• Label: 2014-03-04
• Review: 1997-08-12
• Review: 1997-06-25
• Review: 2000-05-17
• Review: 2001-08-17
• Review: 2012-03-30

Application Sponsors

NDA 019643

MERCK

Marketing Status

• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

002	TABLET;ORAL	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEVACOR	LOVASTATIN
003	TABLET;ORAL	20MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEVACOR	LOVASTATIN
004	TABLET;ORAL	40MG **Federal Register notice that product was not discontinued or withdrawn for safety or efficacy reasons**	1	MEVACOR	LOVASTATIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1987-08-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-07-06	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1988-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-11-22	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1989-03-21
LABELING; Labeling	SUPPL	8	AP	1988-12-20
LABELING; Labeling	SUPPL	9	AP	1988-12-14
LABELING; Labeling	SUPPL	10	AP	1991-02-21
LABELING; Labeling	SUPPL	11	AP	1989-10-20
LABELING; Labeling	SUPPL	12	AP	1991-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-03-12	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1991-04-10
LABELING; Labeling	SUPPL	17	AP	1991-12-19
EFFICACY; Efficacy	SUPPL	18	AP	1991-03-28
LABELING; Labeling	SUPPL	20	AP	1991-10-24
LABELING; Labeling	SUPPL	21	AP	1993-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-11-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1992-12-17	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1993-11-24
LABELING; Labeling	SUPPL	28	AP	1993-11-23
LABELING; Labeling	SUPPL	30	AP	1992-11-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1993-08-09	PRIORITY
LABELING; Labeling	SUPPL	32	AP	1994-05-17	STANDARD
LABELING; Labeling	SUPPL	33	AP	1994-05-17	STANDARD
EFFICACY; Efficacy	SUPPL	34	AP	1995-02-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1994-12-20	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1994-07-05	STANDARD
LABELING; Labeling	SUPPL	37	AP	1994-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1995-08-01	PRIORITY
LABELING; Labeling	SUPPL	40	AP	1996-02-09	STANDARD
LABELING; Labeling	SUPPL	41	AP	1995-01-23	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	1995-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1995-08-08	PRIORITY
LABELING; Labeling	SUPPL	44	AP	1995-08-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1996-04-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1996-12-26	PRIORITY
LABELING; Labeling	SUPPL	47	AP	1997-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1997-03-27	PRIORITY
LABELING; Labeling	SUPPL	50	AP	1997-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1997-06-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1997-11-20	PRIORITY
LABELING; Labeling	SUPPL	53	AP	1998-04-22	STANDARD
LABELING; Labeling	SUPPL	54	AP	1998-06-29	STANDARD
EFFICACY; Efficacy	SUPPL	55	AP	1999-03-11	STANDARD
LABELING; Labeling	SUPPL	56	AP	1998-08-28	STANDARD
LABELING; Labeling	SUPPL	57	AP	1999-03-01	STANDARD
LABELING; Labeling	SUPPL	59	AP	2000-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2000-09-14	PRIORITY
LABELING; Labeling	SUPPL	61	AP	2007-04-17	STANDARD
LABELING; Labeling	SUPPL	62	AP	2001-04-26	STANDARD
LABELING; Labeling	SUPPL	64	AP	2001-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	2001-08-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	66	AP	2001-06-26	PRIORITY
EFFICACY; Efficacy	SUPPL	67	AP	2002-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	68	AP	2002-01-30	PRIORITY
LABELING; Labeling	SUPPL	69	AP	2001-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2002-09-23	PRIORITY
LABELING; Labeling	SUPPL	71	AP	2002-09-20	STANDARD
S; Supplement	SUPPL	73	AP	2003-10-17	PRIORITY
EFFICACY; Efficacy	SUPPL	75	AP	2005-04-07	STANDARD
LABELING; Labeling	SUPPL	76	AP	2005-11-04	STANDARD
LABELING; Labeling	SUPPL	77	AP	2005-06-13	STANDARD
LABELING; Labeling	SUPPL	78	AP	2007-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	79	AP	2007-12-07	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	80	AP	2009-03-09	N/A
LABELING; Labeling	SUPPL	81	AP	2010-06-30	UNKNOWN
LABELING; Labeling	SUPPL	82	AP	2011-06-10	UNKNOWN
LABELING; Labeling	SUPPL	84	AP	2011-02-02	UNKNOWN
LABELING; Labeling	SUPPL	85	AP	2012-02-28	UNKNOWN
LABELING; Labeling	SUPPL	86	AP	2012-10-31	STANDARD
LABELING; Labeling	SUPPL	87	AP	2012-10-31	901 REQUIRED
LABELING; Labeling	SUPPL	88	AP	2014-02-27	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	13	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	31	Null	0
SUPPL	35	Null	0
SUPPL	39	Null	0
SUPPL	43	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	60	Null	0
SUPPL	65	Null	0
SUPPL	66	Null	0
SUPPL	67	Null	6
SUPPL	68	Null	0
SUPPL	70	Null	0
SUPPL	73	Null	0
SUPPL	81	Null	6
SUPPL	82	Null	6
SUPPL	84	Null	7
SUPPL	85	Null	15
SUPPL	86	Null	6
SUPPL	87	Null	6
SUPPL	88	Null	7

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 19643
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)