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FDA NDA · NDA021481

FUZEON

Sponsor: ROCHE

APPLICATION
NDA021481
TYPE
NDA
ORIGINAL APPROVAL
2003-03-13
LATEST ACTION
2019-08-15
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

FUZEON · ReferenceDiscontinued
ENFUVIRTIDE 90MG/VIAL · INJECTABLE · SUBCUTANEOUS

Approval history

2019-08-15Labeling · Supplement 33 · standard — Letter ↗AP
2018-12-27Labeling · Supplement 32 · standard — Letter ↗AP
2015-12-02Labeling · Supplement 30 · standard — Letter ↗AP
2015-06-19Manufacturing (CMC) · Supplement 29 · priorityAP
2014-09-22Manufacturing (CMC) · Supplement 21 · priorityAP
2013-10-31Labeling · Supplement 27 · standard — Label ↗AP
2013-03-13Manufacturing (CMC) · Supplement 26 · priorityAP
2012-08-10Labeling · Supplement 25 · 901 required — Label ↗AP
2011-04-28Efficacy · Supplement 20 · standard — Letter ↗AP
2009-12-22Labeling · Supplement 17 · standard — Letter ↗AP
2008-12-16Labeling · Supplement 15 · standard — Letter ↗AP
2007-01-19Labeling · Supplement 11 · standard — Letter ↗AP
2006-12-20Labeling · Supplement 12 · standard — Letter ↗AP
2006-09-29Efficacy · Supplement 10 · standard — Letter ↗AP
2005-08-12Labeling · Supplement 7 · standard — Label ↗AP
2005-06-29Labeling · Supplement 6 · standard — Letter ↗AP
2004-10-15Efficacy · Supplement 2 · standard — Letter ↗AP
2003-03-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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