Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020972
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SUSTIVA | EFAVIRENZ | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SUSTIVA | EFAVIRENZ | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
| SUSTIVA | EFAVIRENZ | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/08/2023 | SUPPL-59 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021360s047,020972s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021360Orig1s047; 020972Orig1s059ltr.pdf | |
| 10/29/2019 | SUPPL-57 | 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,%20020972Orig1s057ltr.pdf | |
| 10/10/2017 | SUPPL-56 | Labeling-Patient Package Insert, Labeling-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-54 | Labeling-Patient Package Insert, Labeling-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-Patient Package Insert, Labeling-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-Patient Package Insert, Labeling-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-Patient Package Insert, Labeling-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.html |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/08/2023 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021360s047,020972s059lbl.pdf | |
| 10/29/2019 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020972s057,021360s045lbl.pdf | |
| 10/29/2019 | SUPPL-57 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020972s057,021360s045lbl.pdf | |
| 10/10/2017 | SUPPL-56 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf | |
| 10/10/2017 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021360s044,020972s056lbl.pdf | |
| 01/30/2017 | SUPPL-54 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020972s054,021360s042lbl.pdf | |
| 01/30/2017 | SUPPL-54 | Labeling-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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021360s039,020972s051lbl.pdf | |
| 08/31/2016 | SUPPL-51 | Labeling-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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021360s037,020972s048lbl.pdf | |
| 03/27/2015 | SUPPL-48 | Labeling-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-Patient 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 | |
| 05/02/2013 | 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 |