Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021567
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
REYATAZ ATAZANAVIR SULFATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
REYATAZ ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription AB Yes No
REYATAZ ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription AB Yes No
REYATAZ ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;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
06/20/2003 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21567_reyataz_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21567ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021567_reyataz_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/24/2020 SUPPL-44 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021567Orig1s044; 206352Orig1s008ltr.pdf
04/18/2018 SUPPL-42 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021567Orig1s042,206352Orig1s007ltr.pdf
10/20/2017 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s041,206352Orig1s006ltr.pdf
05/23/2017 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021567Orig1s040,206352Orig1s005ltr.pdf
09/15/2016 SUPPL-39 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021567Orig1s039,206352Orig1s004ltr.pdf
09/24/2015 SUPPL-38 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206352Orig1s003,021567Orig1s038ltr.pdf
03/27/2015 SUPPL-37 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s037,206352Orig1s002ltr.pdf
02/26/2015 SUPPL-36 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021567Orig1s036ltr.pdf
06/02/2014 SUPPL-35 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206352Orig1s000,21567Orig1s035ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206352Orig1s000_021567Orig1s035SumR.pdf
02/26/2014 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/15/2013 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf
08/15/2013 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s032,s033ltr.pdf
01/30/2013 SUPPL-31 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021567Orig1s031ltr.pdf
03/14/2012 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s028ltr.pdf
02/17/2012 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021567s027ltr.pdf
10/17/2011 SUPPL-26 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s026ltr.pdf
02/04/2011 SUPPL-25 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021567s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021567Orig1s025.pdf
04/26/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s023ltr.pdf
01/22/2010 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021567s022ltr.pdf
11/05/2009 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021567s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021567s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021567Orig1s019.pdf
02/20/2008 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s018ltr.pdf
09/30/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s017ltr.pdf
08/15/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s016ltr.pdf
03/25/2008 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021567s015ltr.pdf
12/21/2007 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s014ltr.pdf
03/22/2007 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021567s012LTR.pdf
08/09/2006 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf
10/16/2006 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s009ltr.pdf
08/09/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s008, 021567s011LTR.pdf
01/25/2006 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021567s007ltr.pdf
07/18/2005 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021567s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021567s005ltr.pdf
10/05/2004 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567s004ltr.pdf
07/06/2004 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567se2-002_reyataz_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567se2-002ltr.pdf
03/16/2004 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567slr001_reyataz_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21567slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/24/2020 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf
09/24/2020 SUPPL-44 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021567s044,206352s008lbl.pdf
04/18/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021567s042,206352s007lbl.pdf
10/20/2017 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s041,206352s006lbl.pdf
05/23/2017 SUPPL-40 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021567s040,206352s005lbl.pdf
09/15/2016 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021567s039,206352s004lbl.pdf
09/24/2015 SUPPL-38 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206352s003,021567s038lbl.pdf
03/27/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf
03/27/2015 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021567s037,206352s002lbl.pdf
06/02/2014 SUPPL-35 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206352s000,021567s035lbl.pdf
08/15/2013 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf
08/15/2013 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021567s032s033lbl.pdf
03/14/2012 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s028lbl.pdf
02/17/2012 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021567s027lbl.pdf
10/17/2011 SUPPL-26 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s026lbl.pdf
02/04/2011 SUPPL-25 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021567s025lbl.pdf
04/26/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s023lbl.pdf
01/22/2010 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021567s022lbl.pdf
11/05/2009 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021567s019lbl.pdf
09/30/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s017lbl.pdf
08/15/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s016lbl.pdf
03/25/2008 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s015lbl.pdf
02/20/2008 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021567s018lbl.pdf
12/21/2007 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s014lbl.pdf
03/22/2007 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021567s012lbl.pdf
10/16/2006 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf
10/16/2006 SUPPL-9 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf
08/09/2006 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf
08/09/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s008s011lbl.pdf
01/25/2006 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s007lbl.pdf
07/18/2005 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021567s005lbl.pdf
10/05/2004 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567s004lbl.pdf
07/06/2004 SUPPL-2 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567se2-002_reyataz_lbl.pdf
03/16/2004 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21567slr001_reyataz_lbl.pdf
06/20/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21567_reyataz_lbl.pdf

REYATAZ

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 209717 AMNEAL
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 210575 ZYDUS PHARMS
REYATAZ ATAZANAVIR SULFATE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 209717 AMNEAL
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription No AB 210575 ZYDUS PHARMS
REYATAZ ATAZANAVIR SULFATE EQ 200MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB

CAPSULE;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 209717 AMNEAL
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 204806 AUROBINDO PHARMA LTD
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 200626 CIPLA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 091673 TEVA PHARMS USA
ATAZANAVIR SULFATE ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription No AB 210575 ZYDUS PHARMS
REYATAZ ATAZANAVIR SULFATE EQ 300MG BASE CAPSULE;ORAL Prescription Yes AB 021567 BRISTOL MYERS SQUIBB

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English