NDA 021360

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021360

Documents

• Letter: 2002-09-20
• Letter: 2005-04-28
• Letter: 2007-02-02
• Letter: 2009-03-12
• Letter: 2010-04-05
• Letter: 2010-12-03
• Letter: 2011-09-29
• Letter: 2011-12-21
• Letter: 2012-06-26
• Letter: 2013-05-07
• Letter: 2015-04-01
• Letter: 2016-04-01
• Label: 2003-06-22
• Label: 2003-06-22
• Label: 2004-08-25
• Label: 2004-11-01
• Label: 2007-02-05
• Label: 2009-04-23
• Label: 2009-10-01
• Label: 2010-04-04
• Label: 2010-11-29
• Label: 2012-06-26
• Label: 2012-08-15
• Label: 2013-05-03
• Label: 2015-04-02
• Review: 2002-05-15
• Review: 2007-07-20
• Letter: 2002-02-01
• Letter: 2003-06-22
• Letter: 2003-06-22
• Letter: 2003-11-26
• Letter: 2004-08-25
• Letter: 2004-10-29
• Letter: 2007-02-05
• Letter: 2008-08-20
• Letter: 2009-11-10
• Letter: 2012-08-15
• Letter: 2014-05-27
• Label: 2002-02-01
• Label: 2003-12-01
• Label: 2005-04-28
• Label: 2007-02-02
• Label: 2008-08-26
• Label: 2011-09-27
• Label: 2011-12-19
• Label: 2014-05-28
• Label: 2016-04-01
• Review: 2007-07-20
• Letter: 2016-08-31
• Label: 2016-08-31
• Label: 2016-10-17
• Letter: 2017-01-31
• Label: 2017-01-30
• Label: 2017-10-11
• Letter: 2017-10-12
• Letter: 2019-10-30
• Label: 2019-10-30

Application Sponsors

NDA 021360

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SUSTIVA	EFAVIRENZ
002	TABLET;ORAL	600MG	1	SUSTIVA	EFAVIRENZ

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-02-01	STANDARD
LABELING; Labeling	SUPPL	3	AP	2003-06-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2003-06-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2003-11-13	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2004-08-13	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2004-10-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2005-04-20	STANDARD
LABELING; Labeling	SUPPL	14	AP	2006-03-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2007-01-24	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-08-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	2009-03-11	STANDARD
LABELING; Labeling	SUPPL	19	AP	2008-08-18	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-09-23	STANDARD
LABELING; Labeling	SUPPL	23	AP	2010-03-31	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2010-11-30	STANDARD
LABELING; Labeling	SUPPL	26	AP	2011-09-26	STANDARD
LABELING; Labeling	SUPPL	28	AP	2011-12-19	STANDARD
LABELING; Labeling	SUPPL	29	AP	2012-06-22	STANDARD
LABELING; Labeling	SUPPL	30	AP	2012-08-10	901 REQUIRED
EFFICACY; Efficacy	SUPPL	31	AP	2013-05-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2013-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2014-01-22	STANDARD
LABELING; Labeling	SUPPL	35	AP	2014-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	2014-08-14	STANDARD
LABELING; Labeling	SUPPL	37	AP	2015-03-27	STANDARD
LABELING; Labeling	SUPPL	38	AP	2016-03-31	STANDARD
LABELING; Labeling	SUPPL	39	AP	2016-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2016-10-31	STANDARD
LABELING; Labeling	SUPPL	41	AP	2016-10-12	STANDARD
LABELING; Labeling	SUPPL	42	AP	2017-01-30	STANDARD
LABELING; Labeling	SUPPL	44	AP	2017-10-10	STANDARD
LABELING; Labeling	SUPPL	45	AP	2019-10-29	STANDARD

Submissions Property Types

SUPPL	4	Null	9
SUPPL	17	Null	0
SUPPL	21	Null	6
SUPPL	23	Null	7
SUPPL	24	Null	6
SUPPL	26	Null	15
SUPPL	28	Null	15
SUPPL	29	Null	15
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	32	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	15
SUPPL	36	Null	0
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	41	Null	7
SUPPL	42	Null	7
SUPPL	44	Null	7
SUPPL	45	Null	7

TE Codes

002

Prescription

AB

CDER Filings

BRISTOL MYERS SQUIBB

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(
    [0] => Array
        (
            [ApplNo] => 21360
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
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            [originalApprovals] => [{"actionDate":"SUSTIVA","submission":"EFAVIRENZ","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SUSTIVA","submission":"EFAVIRENZ","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-29
        )

)