Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203094
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYBOST COBICISTAT 150MG 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
09/24/2014 ORIG-2 Approval Efficacy STANDARD

Label is not available on this site.

09/24/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203094Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203094Orig1Orig2s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/03/2019 SUPPL-14 Efficacy-New Patient Population, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203094Orig1s014ltr.pdf
08/22/2019 SUPPL-13 Efficacy-New Patient Population, Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203094Orig1s013ltr.pdf
10/30/2018 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203094Orig1s012ltr.pdf
07/27/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203094Orig1s011ltr.pdf
08/28/2017 SUPPL-8 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s008ltr.pdf
05/04/2017 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203094Orig1s007ltr.pdf
06/17/2016 SUPPL-5 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203094Orig1s005ltr.pdf
04/15/2016 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/25/2015 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203094Orig1s003ltr.pdf
04/17/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/15/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/03/2019 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf
10/03/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf
10/03/2019 SUPPL-14 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s014lbl.pdf
08/22/2019 SUPPL-13 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf
08/22/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf
08/22/2019 SUPPL-13 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203094s013lbl.pdf
10/30/2018 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s012lbl.pdf
07/27/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203094s011lbl.pdf
08/28/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf
08/28/2017 SUPPL-8 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s008lbl.pdf
05/04/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf
05/04/2017 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203094s007lbl.pdf
06/17/2016 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf
06/17/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203094s005lbl.pdf
11/25/2015 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203094Orig1s003lbl.pdf
09/24/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203094s000lbl.pdf

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