Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021360
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUSTIVA EFAVIRENZ 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SUSTIVA EFAVIRENZ 600MG TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/01/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21360lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21360ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-360_EfavirenzSustiva.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2019 SUPPL-45 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020972s057,021360s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021360Orig1s045, 020972Orig1s057ltr.pdf
10/10/2017 SUPPL-44 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s044,020972Orig1s056ltr.pdf
01/30/2017 SUPPL-42 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021360Orig1s042,020972Orig1s054ltr.pdf
10/12/2016 SUPPL-41 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
10/31/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

08/31/2016 SUPPL-39 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021360Orig1s039,020972Orig1s051ltr.pdf
03/31/2016 SUPPL-38 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020972Orig1s049,021360Orig1s038ltr.pdf
03/27/2015 SUPPL-37 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021360Orig1s037,020972Orig1s048ltr.pdf
08/14/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

05/23/2014 SUPPL-35 Labeling-Package Insert, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020972Orig1s046,021360Orig1s035ltr.pdf
01/22/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

07/09/2013 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/02/2013 SUPPL-31 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020972Orig1s043,021360Orig1s031ltr.pdf
08/10/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972Orig1s042,021360Orig1s030ltr.pdf
06/22/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020972s041,021360s029ltr.pdf
12/19/2011 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf
09/26/2011 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf
11/30/2010 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021360s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf
03/31/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s035,021360s023ltr.pdf
09/23/2009 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s033,021360s021ltr.pdf
08/18/2008 SUPPL-19 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf
03/11/2009 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020972s031,021360s018ltr.pdf
08/18/2008 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf
01/24/2007 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020972s029, 021360s016ltr.pdf
03/28/2006 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021360s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021360_S014_SUSTIVA.pdf
04/20/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020972s026,021360s013ltr.pdf
10/22/2004 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s024,21360s009ltr.pdf
08/13/2004 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20972s022,21360s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021360_S006_SUSTIVA.pdf
11/13/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr021,21360slr005ltr.pdf
06/10/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf
06/10/2003 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr018,21360slr003ltr.pdf
09/20/2002 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2019 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020972s057,021360s045lbl.pdf
10/29/2019 SUPPL-45 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020972s057,021360s045lbl.pdf
10/10/2017 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf
10/10/2017 SUPPL-44 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf
01/30/2017 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf
01/30/2017 SUPPL-42 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf
10/12/2016 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
10/12/2016 SUPPL-41 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
08/31/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf
08/31/2016 SUPPL-39 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf
03/31/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf
03/31/2016 SUPPL-38 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf
03/27/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf
03/27/2015 SUPPL-37 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf
05/23/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/23/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/23/2014 SUPPL-35 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/02/2013 SUPPL-31 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf
08/10/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf
06/22/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf
12/19/2011 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s028lbl.pdf
09/26/2011 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021360s026lbl.pdf
11/30/2010 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021360s024lbl.pdf
03/31/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf
09/23/2009 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf
03/11/2009 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf
08/18/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf
01/24/2007 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf
03/28/2006 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021360s014lbl.pdf
04/20/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf
10/22/2004 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf
08/13/2004 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf
11/13/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf
06/10/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf
06/10/2003 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf
02/01/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21360lbl.pdf

SUSTIVA

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 205322 AUROBINDO PHARMA LTD
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 204766 CIPLA
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 078886 HETERO LABS LTD III
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 091471 MYLAN
EFAVIRENZ EFAVIRENZ 600MG TABLET;ORAL Prescription No AB 204869 STRIDES PHARMA
SUSTIVA EFAVIRENZ 600MG TABLET;ORAL Prescription Yes AB 021360 BRISTOL MYERS SQUIBB

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