Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205395
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
05/29/2019 SUPPL-14 Labeling-Patient Package Insert, Labeling-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-Package Insert, Labeling-Patient 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-Package Insert, Labeling-Patient 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-Patient Package Insert, Labeling-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-Package Insert, Labeling-Patient 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
05/29/2019 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s014lbl.pdf
05/29/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s014lbl.pdf
01/28/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s012lbl.pdf
01/28/2019 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205395s012lbl.pdf
09/07/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205395s010lbl.pdf
09/07/2018 SUPPL-10 Labeling-Patient 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-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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205395s001lbl.pdf
03/31/2016 SUPPL-1 Labeling-Patient 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

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