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FDA NDA · NDA020857

COMBIVIR

lamivudine and zidovudine

Sponsor: VIIV HLTHCARE

APPLICATION
NDA020857
TYPE
NDA
ORIGINAL APPROVAL
1997-09-26
LATEST ACTION
2019-05-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

COMBIVIR · ReferenceDiscontinued
LAMIVUDINE 150MG, ZIDOVUDINE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2019-05-10Labeling · Supplement 34 · standard — Letter ↗AP
2018-04-27Labeling · Supplement 33 · standard — Letter ↗AP
2017-04-10Labeling · Supplement 32 · standard — Label ↗AP
2017-02-24Labeling · Supplement 31 · standard — Label ↗AP
2015-09-25Labeling · Supplement 30 · standard — Label ↗AP
2011-11-18Labeling · Supplement 28 · 901 required — Letter ↗AP
2010-10-01Labeling · Supplement 26 · unknown — Letter ↗AP
2009-02-02Efficacy · Supplement 23 · priority — Letter ↗AP
2007-04-23Labeling · Supplement 21 · standard — Label ↗AP
2006-10-25Labeling · Supplement 20 · standard — Label ↗AP
2006-06-27Labeling · Supplement 18 · standard — Letter ↗AP
2004-09-29Labeling · Supplement 15 · standard — Label ↗AP
2004-05-17Labeling · Supplement 14 · standard — Label ↗AP
2002-10-08Labeling · Supplement 12 · standard — Letter ↗AP
2002-09-13Manufacturing (CMC) · Supplement 11 · priority — Review ↗AP
2002-08-09Labeling · Supplement 10 · standard — Label ↗AP
2002-08-09Labeling · Supplement 9 · standard — Letter ↗AP
2000-09-29Labeling · Supplement 8 · standard — Review ↗AP
2000-02-01Manufacturing (CMC) · Supplement 7 · priorityAP
2000-01-21Labeling · Supplement 6 · standardAP
1999-04-12Manufacturing (CMC) · Supplement 5 · priorityAP
1999-03-08Labeling · Supplement 3 · standardAP
1999-02-26Manufacturing (CMC) · Supplement 4 · priorityAP
1998-07-31Manufacturing (CMC) · Supplement 2 · priorityAP
1998-02-27Labeling · Supplement 1 · standardAP
1997-09-26Type 4 - New Combination · Original · priorityAP
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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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