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FDA NDA · NDA022128

SELZENTRY

maraviroc

Sponsor: VIIV HLTHCARE

APPLICATION
NDA022128
TYPE
NDA
ORIGINAL APPROVAL
2007-08-06
LATEST ACTION
2020-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

SELZENTRY · ReferenceDiscontinued
MARAVIROC 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SELZENTRY · ReferencePrescription
MARAVIROC 300MG · TABLET · ORAL
SELZENTRY · ReferenceDiscontinued
MARAVIROC 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
SELZENTRY · ReferencePrescription
MARAVIROC 150MG · TABLET · ORAL

Approval history

2020-10-30Efficacy · Supplement 19 · priority — Letter ↗AP
2018-07-18Labeling · Supplement 18 · standard — Label ↗AP
2016-11-04Efficacy · Supplement 17 · priority — Label ↗AP
2015-04-21Labeling · Supplement 15 · standard — Label ↗AP
2014-04-14Manufacturing (CMC) · Supplement 13 · priorityAP
2014-03-27Labeling · Supplement 12 · standard — Letter ↗AP
2013-02-14Labeling · Supplement 11 · standard — Label ↗AP
2013-02-01Labeling · Supplement 10 · standard — Label ↗AP
2012-08-10Labeling · Supplement 9 · 901 required — Label ↗AP
2011-10-21Labeling · Supplement 7 · standard — Label ↗AP
2010-05-27Efficacy · Supplement 4 · standard — Letter ↗AP
2009-11-20Efficacy · Supplement 2 · standard — Letter ↗AP
2008-11-25Efficacy · Supplement 1 · unknown — Letter ↗AP
2007-08-06Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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