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FDA NDA · NDA021652

EPZICOM

Sponsor: VIIV HLTHCARE

APPLICATION
NDA021652
TYPE
NDA
ORIGINAL APPROVAL
2004-08-02
LATEST ACTION
2021-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EPZICOM · ReferenceDiscontinued
ABACAVIR SULFATE EQ 600MG BASE, LAMIVUDINE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-12-10Efficacy · Supplement 29 · standard — Label ↗AP
2021-02-17Labeling · Supplement 28 · standard — Label ↗AP
2019-05-10Labeling · Supplement 24 · standard — Label ↗AP
2018-04-27Labeling · Supplement 23 · standard — Letter ↗AP
2017-03-20Labeling · Supplement 22 · standard — Label ↗AP
2015-09-29Labeling · Supplement 21 · standard — Letter ↗AP
2015-09-17Efficacy · Supplement 19 · standard — Pediatric Medical Review ↗AP
2015-02-19Labeling · Supplement 18 · standard — Label ↗AP
2012-05-18Labeling · Supplement 16 · standard — Label ↗AP
2012-03-12Labeling · Supplement 15 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 14 · 901 required — Label ↗AP
2011-05-13REMS · Supplement 13 — Letter ↗AP
2011-02-02Labeling · Supplement 10 · standard — Letter ↗AP
2010-08-04REMS · Supplement 11 — Letter ↗AP
2009-03-09Labeling · Supplement 8 · standard — Letter ↗AP
2007-05-07Labeling · Supplement 5 · standard — Letter ↗AP
2006-08-11Labeling · Supplement 3 · standard — Letter ↗AP
2004-08-02Type 3 - New Dosage Form · Original · standard — Label ↗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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