NDA 050662

ABBVIE

FDA Drug Application

Application #050662

Documents

• Letter: 2002-06-06
• Letter: 2012-05-09
• Letter: 2011-05-31
• Letter: 2012-06-05
• Letter: 2012-05-09
• Letter: 2013-09-11
• Letter: 2016-05-31
• Letter: 2014-07-28
• Letter: 2015-01-09
• Label: 2000-10-20
• Label: 2007-12-27
• Label: 2009-09-22
• Label: 2012-05-07
• Label: 2011-05-31
• Label: 2012-07-10
• Label: 2013-09-09
• Label: 2013-09-09
• Label: 2015-01-12
• Label: 2015-10-29
• Review: 2004-06-29
• Review: 2004-06-29
• Letter: 2000-10-20
• Letter: 2002-06-06
• Letter: 2004-07-21
• Letter: 2005-10-20
• Letter: 2006-07-13
• Letter: 2008-01-09
• Letter: 2008-05-29
• Letter: 2009-11-20
• Letter: 2011-05-31
• Letter: 2012-07-10
• Letter: 2013-09-11
• Letter: 2015-10-28
• Label: 2005-10-10
• Label: 2011-05-31
• Label: 2012-05-07
• Label: 2016-06-01
• Label: 2014-08-07
• Review: 1999-08-02
• Review: 2004-06-29
• Review: 2001-11-23
• Other Important Information from FDA: 2006-03-03
• Label: 2017-06-12
• Letter: 2017-06-12
• Label: 2018-11-26
• Letter: 2018-12-18
• Label: 2018-12-20
• Letter: 2018-12-31
• Label: 2019-09-19
• Letter: 2019-09-19

Application Sponsors

NDA 050662

ABBVIE

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	BIAXIN	CLARITHROMYCIN
002	TABLET;ORAL	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	BIAXIN	CLARITHROMYCIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-01-28	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1995-02-28	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	1995-02-28	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1993-06-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-09-15	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1993-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1995-03-13	PRIORITY
EFFICACY; Efficacy	SUPPL	10	AP	1996-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-08-31	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1997-08-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	1996-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-10-15	PRIORITY
EFFICACY; Efficacy	SUPPL	15	AP	1997-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1997-01-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-04-29	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1997-09-16	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	1997-09-16	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	1998-09-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-01-05	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1998-07-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-04-27	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1998-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-10-22	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1999-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1999-05-04	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2000-03-20	STANDARD
EFFICACY; Efficacy	SUPPL	29	AP	2000-10-20	STANDARD
LABELING; Labeling	SUPPL	30	AP	2002-06-06	STANDARD
LABELING; Labeling	SUPPL	31	AP	2002-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2002-06-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-11-08	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2004-07-19	STANDARD
LABELING; Labeling	SUPPL	38	AP	2005-10-04	STANDARD
LABELING; Labeling	SUPPL	39	AP	2006-07-05	STANDARD
LABELING; Labeling	SUPPL	40	AP	2007-12-18	STANDARD
LABELING; Labeling	SUPPL	41	AP	2008-05-22	STANDARD
LABELING; Labeling	SUPPL	42	AP	2009-08-14	STANDARD
LABELING; Labeling	SUPPL	43	AP	2011-05-27	STANDARD
LABELING; Labeling	SUPPL	44	AP	2012-05-03	STANDARD
LABELING; Labeling	SUPPL	45	AP	2011-05-27	UNKNOWN
LABELING; Labeling	SUPPL	46	AP	2012-06-01	STANDARD
LABELING; Labeling	SUPPL	48	AP	2012-07-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	2012-11-23	PRIORITY
LABELING; Labeling	SUPPL	50	AP	2012-05-03	STANDARD
LABELING; Labeling	SUPPL	52	AP	2013-09-09	STANDARD
LABELING; Labeling	SUPPL	53	AP	2013-09-09	STANDARD
LABELING; Labeling	SUPPL	54	AP	2016-05-26	STANDARD
LABELING; Labeling	SUPPL	55	AP	2014-07-25	STANDARD
LABELING; Labeling	SUPPL	56	AP	2015-01-08	STANDARD
LABELING; Labeling	SUPPL	57	AP	2015-10-23	STANDARD
LABELING; Labeling	SUPPL	58	AP	2017-06-09	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	59	AP	2018-11-25	STANDARD
LABELING; Labeling	SUPPL	60	AP	2018-12-19	STANDARD
LABELING; Labeling	SUPPL	61	AP	2019-09-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	36	Null	9
SUPPL	42	Null	6
SUPPL	43	Null	6
SUPPL	44	Null	6
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	48	Null	7
SUPPL	49	Null	0
SUPPL	50	Null	6
SUPPL	52	Null	15
SUPPL	53	Null	15
SUPPL	54	Null	6
SUPPL	55	Null	6
SUPPL	56	Null	7
SUPPL	57	Null	15
SUPPL	58	Null	6
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	61	Null	7

CDER Filings

ABBVIE

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(
    [0] => Array
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            [ApplNo] => 50662
            [companyName] => ABBVIE
            [docInserts] => ["",""]
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            [originalApprovals] => [{"actionDate":"BIAXIN","submission":"CLARITHROMYCIN","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"BIAXIN","submission":"CLARITHROMYCIN","actionType":"500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-09-18
        )

)