Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207561
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GENVOYA COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 150MG;150MG;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
11/05/2015 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207561Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207561Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/18/2019 SUPPL-23 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207561s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207561Orig1s023ltr.pdf
11/02/2018 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s020ltr.pdf
12/10/2018 SUPPL-18 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s018ltr.pdf
08/01/2018 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207561Orig1s017Ltr.pdf
09/25/2017 SUPPL-14 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s014ltr.pdf
11/22/2017 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s013ltr.pdf
08/15/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s011ltr.pdf
04/07/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207561Orig1s010ltr.pdf
09/15/2016 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s007ltr.pdf
02/15/2017 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf
02/15/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf
03/08/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s003ltr.pdf
12/07/2016 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207561Orig1s002ltr.pdf
09/07/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/18/2019 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207561s023lbl.pdf
12/10/2018 SUPPL-18 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s018lbl.pdf
11/02/2018 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s020lbl.pdf
08/01/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207561s017lbl.pdf
11/22/2017 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s013lbl.pdf
09/25/2017 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s014lbl.pdf
08/15/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s011lbl.pdf
04/07/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s010lbl.pdf
02/15/2017 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf
02/15/2017 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207561s004s005lbl.pdf
12/07/2016 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s002lbl.pdf
09/15/2016 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s007lbl.pdf
09/07/2016 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s001lbl.pdf
03/08/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207561s003lbl.pdf
11/05/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207561s000lbl.pdf

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