Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205834
Company: GILEAD SCIENCES INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HARVONI LEDIPASVIR; SOFOSBUVIR 90MG;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
10/10/2014 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205834Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205834Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/14/2017 SUPPL-18 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s018ltr.pdf
04/07/2017 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205834Orig1s017ltr.pdf
06/22/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/17/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s011ltr.pdf
06/08/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s010ltr.pdf
02/12/2016 SUPPL-9 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf
02/12/2016 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf
02/12/2016 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205834Orig1s007,s008,s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2016/205834Orig1s007, s008, s009SumR.pdf
11/12/2015 SUPPL-6 Efficacy-New Indication, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s006ltr.pdf
11/12/2015 SUPPL-5 Efficacy-New Indication, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf
11/12/2015 SUPPL-4 Efficacy-New Dosing Regimen, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s004ltr.pdf
11/12/2015 SUPPL-3 Efficacy-New Indication, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s003,s005ltr.pdf
11/12/2015 SUPPL-2 Efficacy-New Patient Population, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s002ltr.pdf
03/20/2015 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205834Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/07/2017 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s017lbl.pdf
02/14/2017 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf
02/14/2017 SUPPL-18 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205834s018lbl.pdf
06/08/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s010lbl.pdf
02/17/2016 SUPPL-11 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834Orig1s011Lbl.pdf
02/12/2016 SUPPL-9 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf
02/12/2016 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf
02/12/2016 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205834s007s008s009lbl.pdf
11/12/2015 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf
11/12/2015 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s006lbl.pdf
11/12/2015 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf
11/12/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf
11/12/2015 SUPPL-4 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf
11/12/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s004lbl.pdf
11/12/2015 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf
11/12/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s003s005lbl.pdf
11/12/2015 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf
11/12/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s002lbl.pdf
03/20/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf
03/20/2015 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205834s001lbl.pdf
10/10/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205834s000lbl.pdf

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