Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022128
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELZENTRY MARAVIROC 150MG TABLET;ORAL Prescription None Yes No
SELZENTRY MARAVIROC 300MG TABLET;ORAL Prescription None Yes Yes
SELZENTRY MARAVIROC 25MG TABLET;ORAL Prescription None Yes No
SELZENTRY MARAVIROC 75MG 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
08/06/2007 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022128s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022128_selzentry_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022128Orig1s018,208984Orig1s001Ltr.pdf
11/04/2016 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208984Orig1s000,022128Orig1s017TOC.cfm
04/21/2015 SUPPL-15 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022128Orig1s015ltr.pdf
04/14/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

03/27/2014 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022128s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022128Orig1s012ltr.pdf
02/14/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s011ltr.pdf
02/01/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022128Orig1s010ltr.pdf
08/10/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022128s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022128Orig1s009ltr.pdf
10/21/2011 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022128s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022128s007ltr.pdf
05/27/2010 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022128s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022128s004ltr.pdf
11/20/2009 SUPPL-2 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022128s002ltr.pdf
11/25/2008 SUPPL-1 Efficacy-Accelerated Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022128s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf
11/04/2016 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf
04/21/2015 SUPPL-15 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf
04/21/2015 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf
04/21/2015 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022128s015lbl.pdf
03/27/2014 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022128s012lbl.pdf
02/14/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s011lbl.pdf
02/01/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022128s010lbl.pdf
08/10/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022128s009lbl.pdf
10/21/2011 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022128s007lbl.pdf
05/27/2010 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022128s004lbl.pdf
11/20/2009 SUPPL-2 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf
08/06/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022128lbl.pdf

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