Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210251
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BIKTARVY BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE EQ 50MG BASE;200MG;EQ 25MG BASE TABLET;ORAL Prescription None Yes Yes
BIKTARVY BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE EQ 30MG BASE;120MG;EQ 15MG BASE TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/07/2018 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210251Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210251Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2021 SUPPL-14 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s014ltr.pdf
09/10/2021 SUPPL-13 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s013ltr.pdf
03/04/2021 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s010ltr.pdf
02/11/2021 SUPPL-9 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s009ltr.pdf
02/24/2021 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s008ltr.pdf
02/05/2021 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210251Orig1s007ltr.pdf
08/02/2019 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s006ltr.pdf
06/18/2019 SUPPL-5 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210251Orig1s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2021 SUPPL-14 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s014lbl.pdf
09/10/2021 SUPPL-13 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf
09/10/2021 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s013lbl.pdf
03/04/2021 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s010lbl.pdf
02/24/2021 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s008lbl.pdf
02/11/2021 SUPPL-9 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf
02/11/2021 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s009lbl.pdf
02/05/2021 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210251s007lbl.pdf
08/02/2019 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s006lbl.pdf
06/18/2019 SUPPL-5 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210251s005lbl.pdf
02/07/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210251s000lbl.pdf

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