Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020972
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUSTIVA EFAVIRENZ 50MG CAPSULE;ORAL Prescription None Yes No
SUSTIVA EFAVIRENZ 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
SUSTIVA EFAVIRENZ 200MG CAPSULE;ORAL Prescription None 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
09/17/1998 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20972lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20972ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20972.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2017 SUPPL-54 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-53 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
08/31/2016 SUPPL-51 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
06/03/2016 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

03/31/2016 SUPPL-49 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-48 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-47 Manufacturing (CMC)

Label is not available on this site.

05/23/2014 SUPPL-46 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-45 Manufacturing (CMC)

Label is not available on this site.

01/15/2014 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

05/02/2013 SUPPL-43 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-42 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-41 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-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s040,021360s028ltr.pdf
09/26/2011 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020972s038,021360s026ltr.pdf
11/30/2010 SUPPL-36 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020972s036,021360s024ltr.pdf
03/31/2010 SUPPL-35 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-33 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
03/11/2009 SUPPL-31 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-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020972s030,021360s017ltr.pdf
01/24/2007 SUPPL-29 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-27 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021360s014,020972s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020972_S027_SUSTIVA.pdf
04/20/2005 SUPPL-26 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-24 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-22 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/2004/020972_S022_SUSTIVA.pdf
11/13/2003 SUPPL-21 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-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_sustiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr019,21360slr004ltr.pdf
06/10/2003 SUPPL-18 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-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972SLR017,%2021360slr001ltr.pdf
01/29/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr016_Sustiva_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20972slr016ltr.pdf
02/28/2002 SUPPL-14 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020972_S014_SUSTIVA.pdf
10/16/2001 SUPPL-13 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf
11/21/2001 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/16/2001 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/12/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2002 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20972s7ltr.pdf
11/14/2000 SUPPL-6 Labeling

Label is not available on this site.

05/31/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/18/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/27/1999 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/09/2000 SUPPL-1 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20972S7LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_s001_Sustiva_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-972_S001_Sustiva.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/30/2017 SUPPL-54 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf
01/30/2017 SUPPL-54 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf
10/12/2016 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
10/12/2016 SUPPL-53 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s053,021360s041lbl.pdf
08/31/2016 SUPPL-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf
08/31/2016 SUPPL-51 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf
03/31/2016 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf
03/31/2016 SUPPL-49 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020972s049-021360s038lbl.pdf
03/27/2015 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf
03/27/2015 SUPPL-48 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf
05/23/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/23/2014 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/23/2014 SUPPL-46 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020972s046,021360s035lbl.pdf
05/02/2013 SUPPL-43 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020972s043,021360s031lbl.pdf
08/10/2012 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s042,021360s030lbl.pdf
06/22/2012 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020972s041,021360s029lbl.pdf
12/19/2011 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s040lbl.pdf
09/26/2011 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020972s038lbl.pdf
11/30/2010 SUPPL-36 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s036lbl.pdf
03/31/2010 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020972s035,021360s023lbl.pdf
09/23/2009 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020972s033,021360s021lbl.pdf
03/11/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021360s018,020972s031lbl.pdf
08/18/2008 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020972s030,021360s019lbl.pdf
01/24/2007 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020972s029,021360s016lbl.pdf
03/28/2006 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020972s027lbl.pdf
04/20/2005 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020972s026,021360s013lbl.pdf
10/22/2004 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s024,21360s009lbl.pdf
08/13/2004 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20972s022,21360s006lbl.pdf
11/13/2003 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr021,21360slr005_sustiva_lbl.pdf
06/10/2003 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr019,21360slr004_sustiva_lbl.pdf
06/10/2003 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr018,21360slr003_sustiva_lbl.pdf
01/29/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20972slr016_Sustiva_lbl.pdf
10/16/2001 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20972s13lbl.pdf
02/09/2000 SUPPL-1 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20972S7LBL.PDF
09/17/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20972lbl.pdf

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