← FDA DRUG APPROVALS

FDA NDA · NDA020518

RETROVIR

Sponsor: VIIV HLTHCARE

APPLICATION
NDA020518
TYPE
NDA
ORIGINAL APPROVAL
1995-12-19
LATEST ACTION
2014-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RETROVIR · ReferenceDiscontinued
ZIDOVUDINE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
RETROVIRDiscontinued
ZIDOVUDINE 200MG · TABLET · ORAL

Approval history

2014-12-23Labeling · Supplement 24 · standard — Letter ↗AP
2012-05-31Labeling · Supplement 23 · standard — Letter ↗AP
2011-11-18Labeling · Supplement 22 · 901 required — Letter ↗AP
2010-05-17Labeling · Supplement 19 · standard — Label ↗AP
2009-11-06Labeling · Supplement 18 · standard — Label ↗AP
2008-09-19Efficacy · Supplement 16 · unknown — Label ↗AP
2006-11-20Labeling · Supplement 15 · standard — Letter ↗AP
2006-05-10Labeling · Supplement 13 · standard — Label ↗AP
2003-10-15Labeling · Supplement 11 · standard — Letter ↗AP
2002-12-18Labeling · Supplement 10 · standard — Letter ↗AP
2002-02-21Labeling · Supplement 9 · standard — Letter ↗AP
2001-10-05Labeling · Supplement 8 · standard — Label ↗AP
2001-03-30Labeling · Supplement 4 · standard — Review ↗AP
2000-02-01Manufacturing (CMC) · Supplement 7 · standardAP
1999-04-02Manufacturing (CMC) · Supplement 6 · standardAP
1999-02-26Manufacturing (CMC) · Supplement 5 · standardAP
1998-06-12Manufacturing (CMC) · Supplement 3 · standardAP
1998-03-04Labeling · Supplement 2 · standardAP
1996-10-04Manufacturing (CMC) · Supplement 1 · standardAP
1995-12-19Type 3 - New Dosage Form · Original · standardAP
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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