Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021567
Company: BRISTOL MYERS SQUIBB
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| REYATAZ | ATAZANAVIR SULFATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| REYATAZ | ATAZANAVIR SULFATE | EQ 150MG BASE | CAPSULE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|
| 04/14/2023 | SUPPL-47 | Manufacturing (CMC)-Facility |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021567Orig1s047ltr.pdf |
| 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-Container/Carton Labels, Labeling-Package Insert |
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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021567s009lbl.pdf | |
| 10/16/2006 | SUPPL-9 | Labeling-Package Insert | 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 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 |
| 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 | 212278 | HETERO LABS LTD III |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212579 | LAURUS |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
| 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 |
| 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 | 212278 | HETERO LABS LTD III |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 212579 | LAURUS |
| ATAZANAVIR SULFATE | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | No | AB | 091673 | TEVA PHARMS USA |
| REYATAZ | ATAZANAVIR SULFATE | EQ 300MG BASE | CAPSULE;ORAL | Prescription | Yes | AB | 021567 | BRISTOL MYERS SQUIBB |