Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204671
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOVALDI SOFOSBUVIR 400MG 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
12/06/2013 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204671Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2017 SUPPL-7 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
04/07/2017 SUPPL-6 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204671Orig1s006ltr.pdf
03/20/2015 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s004ltr.pdf
08/19/2015 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204671Orig1s002ltr.pdf
11/14/2014 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204671Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/07/2017 SUPPL-6 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s006lbl.pdf
02/14/2017 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
02/14/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204671s007lbl.pdf
08/19/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s002lbl.pdf
03/20/2015 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf
03/20/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf
11/14/2014 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204671s001lbl.pdf
12/06/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204671s000lbl.pdf

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