Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210455
Company: JANSSEN PRODS
Company: JANSSEN PRODS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYMTUZA | COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE | 150MG;800MG;200MG;EQ 10MG BASE | 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 |
---|---|---|---|---|---|---|---|
07/17/2018 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210455s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210455Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210455Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/31/2023 | SUPPL-23 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210455Orig1s023ltr.pdf | |
10/20/2022 | SUPPL-22 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210455Orig1s022ltr.pdf | |
04/14/2022 | SUPPL-20 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210455Orig1s020ltr.pdf | |
06/28/2021 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210455Orig1s017ltr.pdf | |
07/29/2021 | SUPPL-16 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210455Orig1s016ltr.pdf | |
12/22/2020 | SUPPL-12 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210455Orig1s012ltr.pdf | |
03/02/2020 | SUPPL-9 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210455Orig1s009ltr.pdf | |
02/25/2019 | SUPPL-5 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s005ltr.pdf | |
05/30/2019 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s004ltr.pdf | |
01/25/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210455Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/31/2023 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf | |
03/31/2023 | SUPPL-23 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210455s023lbl.pdf | |
10/20/2022 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf | |
10/20/2022 | SUPPL-22 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s022lbl.pdf | |
04/14/2022 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf | |
04/14/2022 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210455s020lbl.pdf | |
07/29/2021 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf | |
07/29/2021 | SUPPL-16 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s016lbl.pdf | |
06/28/2021 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210455s017lbl.pdf | |
12/22/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf | |
12/22/2020 | SUPPL-12 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s012lbl.pdf | |
03/02/2020 | SUPPL-9 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210455s009lbl.pdf | |
05/30/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf | |
05/30/2019 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s004lbl.pdf | |
02/25/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf | |
02/25/2019 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s005lbl.pdf | |
01/25/2019 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf | |
01/25/2019 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210455s001lbl.pdf | |
07/17/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210455s000lbl.pdf |