NDA 020972

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020972

Documents

• Letter: 2002-03-01
• Letter: 2003-01-29
• Letter: 2002-09-20
• Letter: 2003-06-22
• Letter: 2004-10-29
• Letter: 2006-04-05
• Letter: 2007-02-02
• Letter: 2010-12-03
• Letter: 2011-12-21
• Letter: 2012-06-26
• Letter: 2013-05-07
• Label: 2003-04-25
• Label: 2003-06-22
• Label: 2003-06-22
• Label: 2003-12-01
• Label: 2004-08-25
• Label: 2004-11-01
• Label: 2005-04-28
• Label: 2007-02-05
• Label: 2009-04-23
• Label: 2010-04-04
• Label: 2011-09-26
• Label: 2012-06-26
• Review: 1998-09-17
• Review: 2004-03-10
• Review: 2007-07-20
• Letter: 1998-09-17
• Letter: 2004-06-18
• Letter: 2003-06-22
• Letter: 2003-11-26
• Letter: 2004-08-25
• Letter: 2005-04-28
• Letter: 2008-08-20
• Letter: 2009-03-12
• Letter: 2009-11-10
• Letter: 2010-04-05
• Letter: 2011-09-29
• Letter: 2012-08-15
• Letter: 2014-05-27
• Letter: 2015-04-01
• Letter: 2016-04-01
• Label: 1998-09-17
• Label: 2000-02-09
• Label: 2003-01-29
• Label: 2007-02-02
• Label: 2008-08-26
• Label: 2009-10-01
• Label: 2010-11-29
• Label: 2011-12-19
• Label: 2012-08-15
• Label: 2013-05-21
• Label: 2014-05-28
• Label: 2015-04-02
• Label: 2016-04-01
• Review: 2007-07-18
• Review: 2007-07-18
• 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
• Pediatric Written Request: 1996-09-17
• Pediatric Amendment 1: 1999-09-17
• Pediatric Amendment 2: 2001-08-08
• Pediatric Amendment 3: 2003-07-02
• Pediatric Amendment 4: 2005-02-28
• Pediatric Amendment 5: 2008-01-31
• Pediatric Amendment 6: 2009-12-23
• Pediatric Amendment 7: 2011-07-18
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2019-10-30
• Label: 2019-10-30

Application Sponsors

NDA 020972

BRISTOL MYERS SQUIBB

Marketing Status

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

Application Products

001	CAPSULE;ORAL	50MG	1	SUSTIVA	EFAVIRENZ
002	CAPSULE;ORAL	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SUSTIVA	EFAVIRENZ
003	CAPSULE;ORAL	200MG	1	SUSTIVA	EFAVIRENZ

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-08-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-05-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-04-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-05-31	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2000-11-14	STANDARD
LABELING; Labeling	SUPPL	7	AP	2002-03-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-04-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-05-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-11-21	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2001-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-02-28	PRIORITY
LABELING; Labeling	SUPPL	16	AP	2003-01-29	STANDARD
LABELING; Labeling	SUPPL	17	AP	2002-09-20	STANDARD
LABELING; Labeling	SUPPL	18	AP	2003-06-10	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-06-10	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-11-13	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2004-08-13	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2004-10-22	STANDARD
LABELING; Labeling	SUPPL	26	AP	2005-04-20	STANDARD
LABELING; Labeling	SUPPL	27	AP	2006-03-28	STANDARD
LABELING; Labeling	SUPPL	29	AP	2007-01-24	STANDARD
LABELING; Labeling	SUPPL	30	AP	2008-08-18	STANDARD
LABELING; Labeling	SUPPL	31	AP	2009-03-11	STANDARD
LABELING; Labeling	SUPPL	33	AP	2009-09-23	STANDARD
LABELING; Labeling	SUPPL	35	AP	2010-03-31	UNKNOWN
LABELING; Labeling	SUPPL	36	AP	2010-11-30	STANDARD
LABELING; Labeling	SUPPL	38	AP	2011-09-26	UNKNOWN
LABELING; Labeling	SUPPL	40	AP	2011-12-19	UNKNOWN
LABELING; Labeling	SUPPL	41	AP	2012-06-22	STANDARD
LABELING; Labeling	SUPPL	42	AP	2012-08-10	901 REQUIRED
EFFICACY; Efficacy	SUPPL	43	AP	2013-05-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	2014-01-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2014-01-22	PRIORITY
LABELING; Labeling	SUPPL	46	AP	2014-05-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	2014-08-14	PRIORITY
LABELING; Labeling	SUPPL	48	AP	2015-03-27	STANDARD
LABELING; Labeling	SUPPL	49	AP	2016-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	2016-06-03	PRIORITY
LABELING; Labeling	SUPPL	51	AP	2016-08-31	STANDARD
LABELING; Labeling	SUPPL	53	AP	2016-10-12	STANDARD
LABELING; Labeling	SUPPL	54	AP	2017-01-30	STANDARD
LABELING; Labeling	SUPPL	56	AP	2017-10-10	STANDARD
LABELING; Labeling	SUPPL	57	AP	2019-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	41
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	19	Null	9
SUPPL	33	Null	7
SUPPL	35	Null	7
SUPPL	36	Null	6
SUPPL	38	Null	7
SUPPL	40	Null	7
SUPPL	41	Null	15
SUPPL	42	Null	6
SUPPL	43	Null	6
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	6
SUPPL	47	Null	0
SUPPL	48	Null	15
SUPPL	49	Null	6
SUPPL	50	Null	0
SUPPL	51	Null	15
SUPPL	53	Null	15
SUPPL	54	Null	6
SUPPL	56	Null	15
SUPPL	57	Null	6

TE Codes

001	Prescription	AB
003	Prescription	AB

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20972
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020972s033,021360s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2009","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021360s018,020972s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2008","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020972s030,021360s019lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2007","submission":"SUPPL-29","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20972s022,21360s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/13\/2003","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20972slr021,21360slr005_sustiva_lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20972slr019,21360slr004_sustiva_lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2003","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20972S7LBL.PDF\"}]","notes":""},{"actionDate":"09\/17\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20972lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SUSTIVA","submission":"EFAVIRENZ","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SUSTIVA","submission":"EFAVIRENZ","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SUSTIVA","submission":"EFAVIRENZ","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-10-29
        )

)