Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202895
Company: JANSSEN PRODS
Company: JANSSEN PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREZISTA | DARUNAVIR | 100MG/ML | SUSPENSION;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 |
|---|---|---|---|---|---|---|---|
| 12/16/2011 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (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 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895_prezista_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202895Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021976s06s068,202895s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021976Orig1s068;202895Orig1s036ltr.pdf | |
| 10/20/2022 | SUPPL-35 | 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-34 | 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-32 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202895Orig1s032ltr.pdf |
| 07/23/2021 | SUPPL-31 | Labeling-Package Insert, Labeling-Patient 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-29 | 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-27 | Labeling-Package Insert, Labeling-Patient 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-25 | 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-24 | 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-22 | Labeling-Package Insert, Labeling-Patient Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202895Orig1s51,021976Orig1s022Ltr.pdf |
| 01/25/2018 | SUPPL-21 | 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-20 | Labeling-Package Insert, Labeling-Patient 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-19 | 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-17 | Efficacy-New Patient Population, Labeling-Package Insert, Labeling-Patient Package Insert |
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 | |
| 03/27/2015 | SUPPL-16 | 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 | |
| 05/27/2015 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient 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-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2014 | SUPPL-11 | 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-10 | 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 | |
| 06/14/2013 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2013 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient 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-6 | Efficacy-New Patient Population |
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-5 | 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-4 | 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 | |
| 11/09/2012 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895Orig1s003ltr.pdf | |
| 06/01/2012 | SUPPL-2 | 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 | |
| 02/17/2012 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202895s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021976s06s068,202895s036lbl.pdf | |
| 10/20/2022 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s067,202895s035lbl.pdf | |
| 04/14/2022 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021976s065,202895s034lbl.pdf | |
| 07/23/2021 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976s062,202895s031lbl.pdf | |
| 07/23/2021 | SUPPL-31 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021976s062,202895s031lbl.pdf | |
| 12/22/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021976s059,202895s029lbl.pdf | |
| 12/22/2020 | SUPPL-29 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021976s059,202895s029lbl.pdf | |
| 05/28/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s056,202895s027lbl.pdf | |
| 05/28/2019 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s056,202895s027lbl.pdf | |
| 03/21/2019 | SUPPL-24 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s053,202895s024lbl.pdf | |
| 01/31/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf | |
| 01/31/2019 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021976s054,202895s025lbl.pdf | |
| 01/25/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf | |
| 01/25/2018 | SUPPL-21 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021976s047_202895S021lbl.pdf | |
| 06/19/2017 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf | |
| 06/19/2017 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021976s045_202895s020lbl.pdf | |
| 09/15/2016 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf | |
| 06/17/2016 | SUPPL-17 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf | |
| 06/17/2016 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf | |
| 06/17/2016 | SUPPL-17 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf | |
| 05/27/2015 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf | |
| 05/27/2015 | SUPPL-13 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf | |
| 03/27/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf | |
| 03/27/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf | |
| 04/07/2014 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf | |
| 04/07/2014 | SUPPL-11 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf | |
| 11/07/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf | |
| 11/07/2013 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf | |
| 04/24/2013 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf | |
| 02/22/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf | |
| 02/22/2013 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf | |
| 02/01/2013 | SUPPL-6 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf | |
| 02/01/2013 | SUPPL-5 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf | |
| 11/09/2012 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf | |
| 11/09/2012 | SUPPL-3 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s003lbl.pdf | |
| 06/01/2012 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf | |
| 02/17/2012 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202895s001lbl.pdf | |
| 12/16/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf |