← FDA DRUG APPROVALS

FDA NDA · NDA020977

ZIAGEN

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APPLICATION
NDA020977
TYPE
NDA
ORIGINAL APPROVAL
1998-12-17
LATEST ACTION
2020-11-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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ABACAVIR SULFATE EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2020-11-24Labeling · Supplement 35 · standard — Label ↗AP
2018-05-09Labeling · Supplement 33 · standard — Letter ↗AP
2018-05-09Labeling · Supplement 34 · standard — Letter ↗AP
2017-03-20Labeling · Supplement 32 · standard — Label ↗AP
2015-09-30Labeling · Supplement 30 · standard — Letter ↗AP
2015-07-21Manufacturing (CMC) · Supplement 29 · priorityAP
2015-03-23Efficacy · Supplement 27 · standard — Letter ↗AP
2015-02-19Labeling · Supplement 28 · standard — Label ↗AP
2013-09-11Labeling · Supplement 26 · standard — Letter ↗AP
2012-05-18Labeling · Supplement 25 · standard — Letter ↗AP
2012-03-15Labeling · Supplement 24 · standard — Label ↗AP
2011-11-18Labeling · Supplement 23 · 901 required — Label ↗AP
2011-05-13REMS · Supplement 22 — Letter ↗AP
2010-08-04REMS · Supplement 20 — Letter ↗AP
2008-12-19Labeling · Supplement 19 · 901 order — Pediatric Medical Review ↗AP
2008-07-18Efficacy · Supplement 17 · unknown — Label ↗AP
2007-05-07Labeling · Supplement 16 · standard — Letter ↗AP
2006-08-11Labeling · Supplement 14 · standard — Review ↗AP
2004-08-02Efficacy · Supplement 12 · unknown — Label ↗AP
2004-07-26Labeling · Supplement 13 · standard — Letter ↗AP
2004-04-15Efficacy · Supplement 11 · unknown — Letter ↗AP
2003-07-17Labeling · Supplement 10 · standard — Letter ↗AP
2002-10-02Labeling · Supplement 7 · standard — Label ↗AP
2002-08-14Labeling · Supplement 8 · standard — Label ↗AP
2002-06-04Labeling · Supplement 6 · standardAP
2002-01-28Labeling · Supplement 5 · standard — Letter ↗AP
2001-07-13Manufacturing (CMC) · Supplement 4 · priorityAP
2000-12-15Efficacy · Supplement 2 · standard — Review ↗AP
2000-07-27Labeling · Supplement 3 · standardAP
2000-04-20Labeling · Supplement 1 · standardAP
1998-12-17Type 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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