Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021976
Company: JANSSEN PRODS
Company: JANSSEN PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREZISTA | DARUNAVIR | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PREZISTA | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | AB | Yes | No |
| PREZISTA | DARUNAVIR | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| PREZISTA | DARUNAVIR | 75MG | TABLET;ORAL | Prescription | None | Yes | No |
| PREZISTA | DARUNAVIR | 150MG | TABLET;ORAL | Prescription | None | Yes | No |
| PREZISTA | DARUNAVIR | 800MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/2006 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021976s000_SprycelTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021976s06s068,202895s036lbl.pdf | |
| 10/20/2022 | SUPPL-67 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s067,202895s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021976Orig1s067,202895Orig1s035ltr.pdf | |
| 04/14/2022 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s065,202895s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021976Orig1s065; 202895Orig1s034ltr.pdf | |
| 08/17/2021 | SUPPL-63 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976Orig1s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021976Orig1s063ltr.pdf | |
| 07/23/2021 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976s062,202895s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021976Orig1s062; 202895Orig1s031ltr.pdf | |
| 12/22/2020 | SUPPL-59 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021976s059,202895s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202895Orig1s029, 021976Orig1s059ltr.pdf | |
| 05/28/2019 | SUPPL-56 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s056,202895s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021976Orig1s056, 202895Orig1s027ltr.pdf | |
| 01/31/2019 | SUPPL-54 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021976Orig1s054, 202895Orig1s025ltr.pdf | |
| 03/21/2019 | SUPPL-53 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s053,202895s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021976Orig1s053,202895Orig1s024ltr.pdf | |
| 09/07/2018 | SUPPL-51 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202895Orig1s51,021976Orig1s022Ltr.pdf | |
| 01/25/2018 | SUPPL-47 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021976Orig1s047,202895Orig1s021ltr.pdf | |
| 06/19/2017 | SUPPL-45 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021976Orig1s045,202895Orig1s020ltr.pdf | |
| 09/15/2016 | SUPPL-44 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf | |
| 06/17/2016 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf | |
| 04/11/2016 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf | |
| 02/19/2016 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/2015 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2015 | SUPPL-36 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf | |
| 05/08/2014 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2014 | SUPPL-34 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf | |
| 11/07/2013 | SUPPL-33 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf | |
| 10/31/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/14/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2013 | SUPPL-30 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf | |
| 02/01/2013 | SUPPL-29 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf | |
| 02/01/2013 | SUPPL-28 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf | |
| 04/24/2013 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf | |
| 06/01/2012 | SUPPL-26 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf | |
| 11/09/2012 | SUPPL-25 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf | |
| 02/17/2012 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s022ltr.pdf | |
| 02/13/2012 | SUPPL-21 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s021ltr.pdf | |
| 12/16/2011 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf | |
| 10/19/2011 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021976s018ltr.pdf | |
| 12/13/2010 | SUPPL-17 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s017ltr.pdf | |
| 04/26/2010 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s016ltr.pdf | |
| 01/27/2010 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf | |
| 01/27/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf | |
| 06/15/2009 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s011ltr.pdf | |
| 06/15/2009 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s010ltr.pdf | |
| 12/18/2008 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s009ltr.pdf | |
| 10/21/2008 | SUPPL-7 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s007ltr.pdf | |
| 10/21/2008 | SUPPL-6 | Efficacy-Accelerated Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s006ltr.pdf |
| 02/25/2008 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s005ltr.pdf | |
| 03/07/2008 | SUPPL-4 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf | |
| 03/07/2008 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf | |
| 04/25/2007 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2006 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021976s06s068,202895s036lbl.pdf | |
| 10/20/2022 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s067,202895s035lbl.pdf | |
| 04/14/2022 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s065,202895s034lbl.pdf | |
| 08/17/2021 | SUPPL-63 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976Orig1s063lbl.pdf | |
| 08/17/2021 | SUPPL-63 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976Orig1s063lbl.pdf | |
| 07/23/2021 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976s062,202895s031lbl.pdf | |
| 12/22/2020 | SUPPL-59 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021976s059,202895s029lbl.pdf | |
| 12/22/2020 | SUPPL-59 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021976s059,202895s029lbl.pdf | |
| 05/28/2019 | SUPPL-56 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s056,202895s027lbl.pdf | |
| 05/28/2019 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s056,202895s027lbl.pdf | |
| 03/21/2019 | SUPPL-53 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s053,202895s024lbl.pdf | |
| 01/31/2019 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf | |
| 01/31/2019 | SUPPL-54 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf | |
| 09/07/2018 | SUPPL-51 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf | |
| 09/07/2018 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s051,202895s022lbl.pdf | |
| 01/25/2018 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf | |
| 01/25/2018 | SUPPL-47 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf | |
| 06/19/2017 | SUPPL-45 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf | |
| 06/19/2017 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf | |
| 09/15/2016 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf | |
| 06/17/2016 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf | |
| 05/27/2015 | SUPPL-36 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf | |
| 05/27/2015 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf | |
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf | |
| 03/27/2015 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf | |
| 04/07/2014 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf | |
| 04/07/2014 | SUPPL-34 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf | |
| 11/07/2013 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf | |
| 11/07/2013 | SUPPL-33 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf | |
| 04/24/2013 | SUPPL-27 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf | |
| 02/22/2013 | SUPPL-30 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf | |
| 02/22/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf | |
| 02/01/2013 | SUPPL-29 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf | |
| 02/01/2013 | SUPPL-28 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf | |
| 11/09/2012 | SUPPL-25 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf |
| 06/01/2012 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf | |
| 06/01/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf | |
| 02/17/2012 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf | |
| 02/13/2012 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf | |
| 02/13/2012 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf | |
| 12/16/2011 | SUPPL-20 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf | |
| 10/19/2011 | SUPPL-18 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf | |
| 12/13/2010 | SUPPL-17 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf | |
| 04/26/2010 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf | |
| 01/27/2010 | SUPPL-13 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf | |
| 01/27/2010 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf | |
| 06/15/2009 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf | |
| 06/15/2009 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf | |
| 12/18/2008 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf | |
| 10/21/2008 | SUPPL-7 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf | |
| 03/07/2008 | SUPPL-4 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf | |
| 03/07/2008 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf | |
| 02/25/2008 | SUPPL-5 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf | |
| 11/20/2006 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf | |
| 06/23/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf |
PREZISTA
TABLET;ORAL; 600MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 212493 | AMNEAL |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 210677 | AUROBINDO PHARMA LTD |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 206288 | CIPLA |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 211578 | DR REDDYS |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 202083 | HETERO LABS LTD III |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 202073 | LUPIN LTD |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 215389 | MSN |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 202118 | TEVA PHARMS USA |
| DARUNAVIR | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | No | AB | 214085 | ZYDUS LIFESCIENCES |
| PREZISTA | DARUNAVIR | 600MG | TABLET;ORAL | Prescription | Yes | AB | 021976 | JANSSEN PRODS |
TABLET;ORAL; 800MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 212493 | AMNEAL |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 210677 | AUROBINDO PHARMA LTD |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 206288 | CIPLA |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 211578 | DR REDDYS |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 202073 | LUPIN LTD |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 215389 | MSN |
| DARUNAVIR | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | No | AB | 214085 | ZYDUS LIFESCIENCES |
| PREZISTA | DARUNAVIR | 800MG | TABLET;ORAL | Prescription | Yes | AB | 021976 | JANSSEN PRODS |