Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 205395
Company: JANSSEN PRODS
Company: JANSSEN PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREZCOBIX | COBICISTAT; DARUNAVIR | 150MG;800MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/29/2015 | ORIG-1 | Approval | Type 4 - New Combination | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205395s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205395Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205395Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205395s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205395Orig1s025ltr.pdf | |
| 10/20/2022 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205395Orig1s024ltr.pdf | |
| 04/14/2022 | SUPPL-22 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205395Orig1s022ltr.pdf | |
| 07/23/2021 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205395s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205395Orig1s020ltr.pdf | |
| 12/22/2020 | SUPPL-18 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205395s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205395Orig1s018ltr.pdf | |
| 07/31/2020 | SUPPL-16 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205395s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205395Orig1s016ltr.pdf | |
| 05/29/2019 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205395Orig1s014ltr.pdf | |
| 01/28/2019 | SUPPL-12 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205395Orig1s012ltr.pdf | |
| 09/07/2018 | SUPPL-10 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1so10Ltr.pdf | |
| 06/04/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s009ltr.pdf | |
| 01/25/2018 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s006s007ltr.pdf | |
| 01/25/2018 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205395Orig1s006s007ltr.pdf | |
| 06/14/2017 | SUPPL-4 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205395s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205395Orig1s004ltr.pdf | |
| 09/22/2016 | SUPPL-2 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s002ltr.pdf | |
| 03/31/2016 | SUPPL-1 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205395Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/31/2023 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205395s025lbl.pdf | |
| 03/31/2023 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205395s025lbl.pdf | |
| 10/20/2022 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s024lbl.pdf | |
| 10/20/2022 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s024lbl.pdf | |
| 04/14/2022 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s022lbl.pdf | |
| 04/14/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205395s022lbl.pdf | |
| 07/23/2021 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205395s020lbl.pdf | |
| 07/23/2021 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205395s020lbl.pdf | |
| 12/22/2020 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205395s018lbl.pdf | |
| 12/22/2020 | SUPPL-18 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205395s018lbl.pdf | |
| 07/31/2020 | SUPPL-16 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205395s016lbl.pdf | |
| 05/29/2019 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s014lbl.pdf | |
| 05/29/2019 | SUPPL-14 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s014lbl.pdf | |
| 01/28/2019 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s012lbl.pdf | |
| 01/28/2019 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s012lbl.pdf | |
| 09/07/2018 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s010lbl.pdf | |
| 09/07/2018 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s010lbl.pdf | |
| 06/04/2018 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s009lbl.pdf | |
| 01/25/2018 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf | |
| 01/25/2018 | SUPPL-7 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf | |
| 01/25/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf | |
| 01/25/2018 | SUPPL-6 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395S6S7lbl.pdf | |
| 06/14/2017 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205395s004lbl.pdf | |
| 06/14/2017 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205395s004lbl.pdf | |
| 09/22/2016 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s002lbl.pdf | |
| 09/22/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s002lbl.pdf | |
| 03/31/2016 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf | |
| 03/31/2016 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf | |
| 01/29/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205395s000lbl.pdf |