NDA 017963

US PHARMS HOLDINGS I

FDA Drug Application

Application #017963

Documents

• Letter: 2006-09-18
• Letter: 2008-07-30
• Letter: 2010-01-06
• Letter: 2012-12-26
• Label: 2013-01-11
• Label: 2013-03-15
• Letter: 2003-09-25
• Letter: 2008-01-09
• Letter: 2013-03-15
• Label: 2008-07-29
• Label: 2009-11-23
• Label: 2011-03-21

Application Sponsors

NDA 017963

US PHARMS HOLDINGS I

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	1	LOPRESSOR	METOPROLOL TARTRATE
002	TABLET;ORAL	100MG	1	LOPRESSOR	METOPROLOL TARTRATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-08-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1979-04-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1979-04-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1979-03-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1979-08-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-04-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1979-10-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1979-04-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1979-10-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1979-10-24	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1980-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1981-03-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1980-05-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1980-02-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1980-01-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1980-09-03	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1981-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1981-01-15	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1981-04-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1981-09-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1982-03-26	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	1984-03-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1982-10-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1983-05-17	PRIORITY
EFFICACY; Efficacy	SUPPL	28	AP	1983-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1984-12-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1984-02-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1984-06-28	PRIORITY
EFFICACY; Efficacy	SUPPL	34	AP	1986-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1985-01-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1985-07-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1985-10-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1985-11-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1988-02-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1988-05-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1989-01-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1989-10-26	PRIORITY
LABELING; Labeling	SUPPL	46	AP	1990-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1991-01-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1995-02-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1995-11-02	PRIORITY
LABELING; Labeling	SUPPL	51	AP	1999-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1999-02-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1999-04-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	2000-05-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	2001-07-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2002-04-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2002-06-14	PRIORITY
LABELING; Labeling	SUPPL	58	AP	2003-09-12	STANDARD
LABELING; Labeling	SUPPL	59	AP	2006-09-05	STANDARD
LABELING; Labeling	SUPPL	61	AP	2008-01-08	STANDARD
LABELING; Labeling	SUPPL	62	AP	2008-07-24	STANDARD
LABELING; Labeling	SUPPL	63	AP	2009-11-20	STANDARD
LABELING; Labeling	SUPPL	64	AP	2011-03-15	UNKNOWN
LABELING; Labeling	SUPPL	67	AP	2012-12-21	UNKNOWN
LABELING; Labeling	SUPPL	68	AP	2013-03-14	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	69	AP	2014-10-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	70	AP	2014-10-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	71	AP	2016-03-21	PRIORITY

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	47	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	63	Null	7
SUPPL	64	Null	6
SUPPL	67	Null	7
SUPPL	68	Null	15
SUPPL	69	Null	0
SUPPL	70	Null	0
SUPPL	71	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

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            [ApplNo] => 17963
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

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