Drugs@FDA: FDA Approved Drug Products

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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
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
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
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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