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FDA NDA · NDA021003

EPIVIR-HBV

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA021003
TYPE
NDA
ORIGINAL APPROVAL
1998-12-08
LATEST ACTION
2021-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

EPIVIR-HBV · ReferenceDiscontinued
LAMIVUDINE 100MG · TABLET · ORAL

Approval history

2021-12-22Labeling · Supplement 23 · standard — Letter ↗AP
2018-11-15Efficacy · Supplement 20 · standard — Label ↗AP
2017-09-27Labeling · Supplement 17 · standard — Label ↗AP
2017-05-08Labeling · Supplement 16 · standard — Label ↗AP
2013-12-20Labeling · Supplement 15 · standard — Label ↗AP
2011-01-21Labeling · Supplement 13 · 901 required — Letter ↗AP
2007-09-26Labeling · Supplement 10 · standard — Label ↗AP
2004-11-22Labeling · Supplement 5 · standard — Letter ↗AP
2004-09-27Labeling · Supplement 6 · standard — Letter ↗AP
2003-11-13Labeling · Supplement 4 · standard — Letter ↗AP
2002-09-13Manufacturing (CMC) · Supplement 3 · priorityAP
2001-08-16Efficacy · Supplement 2 · standard — Review ↗AP
2000-03-31Labeling · Supplement 1 · standardAP
1998-12-08Type 3 - New Dosage Form · Original · priority — Letter ↗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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