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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022128
Company: VIIV HLTHCARE

Medication Guide

Products on NDA 022128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SELZENTRY	MARAVIROC	150MG	TABLET;ORAL	Prescription	AB	Yes	No
SELZENTRY	MARAVIROC	300MG	TABLET;ORAL	Prescription	AB	Yes	Yes
SELZENTRY	MARAVIROC	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
SELZENTRY	MARAVIROC	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022128

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
10/30/2020	SUPPL-19	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-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-Patient Package Insert, Labeling-Package Insert, Labeling-Medication Guide	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

Labels for NDA 022128

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2020	SUPPL-19	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022128Orig1s019,208984Orig1s002lbl.pdf
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-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
04/21/2015	SUPPL-15	Labeling-Medication Guide	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

Therapeutic Equivalents for NDA 022128

SELZENTRY

TABLET;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	203347	HETERO LABS LTD III
MARAVIROC	MARAVIROC	150MG	TABLET;ORAL	Prescription	No	AB	217114	I 3 PHARMS
SELZENTRY	MARAVIROC	150MG	TABLET;ORAL	Prescription	Yes	AB	022128	VIIV HLTHCARE

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	203347	HETERO LABS LTD III
MARAVIROC	MARAVIROC	300MG	TABLET;ORAL	Prescription	No	AB	217114	I 3 PHARMS
SELZENTRY	MARAVIROC	300MG	TABLET;ORAL	Prescription	Yes	AB	022128	VIIV HLTHCARE

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