Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208215
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG 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
04/04/2016 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208215Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208215Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2021 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/0208215Orig1s019ltr.pdf
03/04/2021 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s017ltr.pdf
11/24/2020 SUPPL-14 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208215Orig1s014ltr.pdf
10/03/2019 SUPPL-12 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/208215Orig1s012.pdf
12/03/2019 SUPPL-11 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208215Orig1s011ltr.pdf
09/28/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208215Orig1s005ltr.pdf
04/07/2017 SUPPL-1 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/15/2021 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf
03/04/2021 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf
11/24/2020 SUPPL-14 Manufacturing (CMC) Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208215Orig1s014lbl.pdf
12/03/2019 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s011lbl.pdf
10/03/2019 SUPPL-12 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208215s012lbl.pdf
09/28/2017 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s005lbl.pdf
04/07/2017 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208215s001lbl.pdf
04/04/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208215s000lbl.pdf

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