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FDA NDA · NDA020413

ZERIT

Sponsor: BRISTOL

APPLICATION
NDA020413
TYPE
NDA
ORIGINAL APPROVAL
1996-09-06
LATEST ACTION
2018-12-17
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

ZERIT · ReferenceDiscontinued
STAVUDINE 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL

Approval history

2018-12-17Labeling · Supplement 33 · standard — Medication Guide ↗AP
2017-12-19Labeling · Supplement 32 · standard — Label ↗AP
2011-11-18Labeling · Supplement 30 · 901 required — Label ↗AP
2011-05-11REMS · Supplement 29 — Letter ↗AP
2010-12-10Labeling · Supplement 28 · standard — Label ↗AP
2009-07-08Labeling · Supplement 26 · standard — Letter ↗AP
2009-02-13Labeling · Supplement 25 · standard — Label ↗AP
2008-12-11Labeling · Supplement 23 · standard — Label ↗AP
2008-04-14Manufacturing (CMC) · Supplement 21 — Label ↗AP
2008-04-14Labeling · Supplement 20 · standard — Label ↗AP
2007-06-20Labeling · Supplement 18 · standard — Letter ↗AP
2005-12-20Labeling · Supplement 15 · priority — Label ↗AP
2004-06-04Labeling · Supplement 14 · standard — Letter ↗AP
2002-03-29Efficacy · Supplement 7 · standard — Label ↗AP
2002-02-20Labeling · Supplement 8 · standard — Letter ↗AP
2002-02-20Labeling · Supplement 9 · standard — Letter ↗AP
2001-10-16Labeling · Supplement 6 · standard — Label ↗AP
2000-09-27Labeling · Supplement 5 · standardAP
1999-07-01Efficacy · Supplement 3 · standardAP
1998-09-16Labeling · Supplement 4 · standardAP
1998-08-19Manufacturing (CMC) · Supplement 2 · priorityAP
1998-02-04Labeling · Supplement 1 · standardAP
1996-09-06Type 3 - New Dosage Form · Original · priorityAP
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