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FDA NDA · NDA020412

ZERIT

Sponsor: BRISTOL

APPLICATION
NDA020412
TYPE
NDA
ORIGINAL APPROVAL
1994-06-24
LATEST ACTION
2018-12-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ZERITDiscontinued
STAVUDINE 5MG · CAPSULE · ORAL
ZERIT · ReferenceDiscontinued
STAVUDINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZERIT · ReferenceDiscontinued
STAVUDINE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZERIT · ReferenceDiscontinued
STAVUDINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
ZERIT · ReferenceDiscontinued
STAVUDINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2018-12-17Labeling · Supplement 41 · standard — Label ↗AP
2017-12-19Labeling · Supplement 40 · standard — Label ↗AP
2015-07-14Manufacturing (CMC) · Supplement 39 · priorityAP
2011-11-18Labeling · Supplement 38 · 901 required — Letter ↗AP
2011-05-11REMS · Supplement 37 — Letter ↗AP
2010-12-10Labeling · Supplement 36 · standard — Label ↗AP
2009-07-08Labeling · Supplement 34 · standard — Letter ↗AP
2009-02-13Labeling · Supplement 33 · standard — Letter ↗AP
2008-12-11Labeling · Supplement 32 · standard — Letter ↗AP
2008-04-14Labeling · Supplement 30 · standard — Label ↗AP
2008-04-14Labeling · Supplement 29 · standard — Letter ↗AP
2007-06-20Labeling · Supplement 27 · standard — Letter ↗AP
2005-12-20Labeling · Supplement 24 · priority — Label ↗AP
2004-06-04Labeling · Supplement 23 · standard — Letter ↗AP
2002-03-29Efficacy · Supplement 16 · standard — Label ↗AP
2002-02-20Labeling · Supplement 18 · standard — Letter ↗AP
2002-02-20Labeling · Supplement 17 · standard — Letter ↗AP
2001-10-16Labeling · Supplement 15 · standard — Label ↗AP
2001-04-17Manufacturing (CMC) · Supplement 14 · priorityAP
2000-09-27Labeling · Supplement 13 · standardAP
1999-07-01Efficacy · Supplement 10 · standardAP
1999-06-10Manufacturing (CMC) · Supplement 12 · priorityAP
1998-09-16Labeling · Supplement 11 · standardAP
1998-08-19Manufacturing (CMC) · Supplement 9 · priorityAP
1998-02-04Labeling · Supplement 5 · standardAP
1998-02-03Manufacturing (CMC) · Supplement 7 · priorityAP
1998-01-16Manufacturing (CMC) · Supplement 8 · priorityAP
1997-09-26Manufacturing (CMC) · Supplement 6 · priorityAP
1996-09-06Efficacy · Supplement 4 · priorityAP
1996-02-09Manufacturing (CMC) · Supplement 3 · priorityAP
1995-12-21Efficacy · Supplement 2 · unknownAP
1994-08-02Manufacturing (CMC) · Supplement 1 · priorityAP
1994-06-24Type 1 - New Molecular Entity · 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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