Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202258
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VICTRELIS BOCEPREVIR 200MG CAPSULE;ORAL Discontinued None No 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
05/13/2011 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/2011/202258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202258Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202258Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/30/2017 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202258Orig1s016ltr.pdf
07/28/2014 SUPPL-15 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s015ltr.pdf
02/24/2014 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s014ltr.pdf
02/07/2014 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s013ltr.pdf
01/17/2014 SUPPL-12 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s012ltr.pdf
04/09/2014 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202258Orig1s011ltr.pdf
09/18/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s009ltr.pdf
07/22/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/15/2013 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s007ltr.pdf
12/21/2012 SUPPL-6 Labeling, Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s006ltr.pdf
11/02/2012 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s005ltr.pdf
02/27/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s004ltr.pdf
02/13/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202258Orig1s003ltr.pdf
04/20/2012 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258s002ltr.pdf
07/30/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202258Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/30/2017 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf
01/30/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202258s016lbl.pdf
07/28/2014 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf
07/28/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s015lbl.pdf
04/09/2014 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s011lbl.pdf
02/24/2014 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf
02/24/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s014lbl.pdf
02/07/2014 SUPPL-13 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf
02/07/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s013lbl.pdf
01/17/2014 SUPPL-12 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf
01/17/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202258s012lbl.pdf
09/18/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s009lbl.pdf
02/27/2013 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s004lbl.pdf
02/15/2013 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf
02/15/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s007lbl.pdf
02/13/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202258s003lbl.pdf
12/21/2012 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf
12/21/2012 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf
12/21/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s006lbl.pdf
11/02/2012 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s005lbl.pdf
07/30/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s001lbl.pdf
04/20/2012 SUPPL-2 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf
04/20/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202258s002lbl.pdf
05/13/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202258lbl.pdf

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