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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208984
Company: VIIV HLTHCARE

Medication Guide

Products on NDA 208984

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELZENTRY	MARAVIROC	20MG/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208984

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/04/2016	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208984Orig1s000,022128Orig1s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208984Orig1s000,022128Orig1s017TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2020	SUPPL-2	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128Orig1s019,208984Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022128Orig1s019; 208984Orig1s002ltr.pdf
07/18/2018	SUPPL-1	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

Labels for NDA 208984

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2020	SUPPL-2	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128Orig1s019,208984Orig1s002lbl.pdf
07/18/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022128s018,208984s001lbl.pdf
11/04/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208984_022128s017lbl.pdf

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