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FDA NDA · NDA022116

LEXIVA

Sponsor: VIIV HLTHCARE

APPLICATION
NDA022116
TYPE
NDA
ORIGINAL APPROVAL
2007-06-14
LATEST ACTION
2019-03-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

LEXIVA · ReferenceDiscontinued
FOSAMPRENAVIR CALCIUM EQ 50MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2019-03-28Labeling · Supplement 25 · standard — Letter ↗AP
2017-12-01Labeling · Supplement 24 · standard — Label ↗AP
2016-09-15Labeling · Supplement 23 · standard — Label ↗AP
2016-03-22Labeling · Supplement 21 · standard — Label ↗AP
2015-07-17Labeling · Supplement 19 · standard — Letter ↗AP
2015-03-27Labeling · Supplement 20 · 901 required — Label ↗AP
2013-02-12Labeling · Supplement 15 · standard — Label ↗AP
2012-04-27Efficacy · Supplement 12 · priority — Label ↗AP
2012-02-17Labeling · Supplement 13 · 901 required — Label ↗AP
2011-05-10Labeling · Supplement 10 · standard — Label ↗AP
2010-04-26Labeling · Supplement 8 · unknown — Label ↗AP
2009-09-11Labeling · Supplement 5 · standard — Letter ↗AP
2009-04-14Labeling · Supplement 4 · standard — Letter ↗AP
2008-04-30Labeling · Supplement 3 · standard — Letter ↗AP
2008-03-05Labeling · Supplement 1 · standard — Label ↗AP
2007-06-14Type 3 - New Dosage Form · 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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