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FDA NDA · NDA021453

ZERIT XR

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021453
TYPE
NDA
ORIGINAL APPROVAL
2002-12-31
LATEST ACTION
2005-01-19
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ZERIT XRDiscontinued
STAVUDINE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
ZERIT XRDiscontinued
STAVUDINE 50MG · CAPSULE, EXTENDED RELEASE · ORAL
ZERIT XRDiscontinued
STAVUDINE 75MG · CAPSULE, EXTENDED RELEASE · ORAL
ZERIT XRDiscontinued
STAVUDINE 37.5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2005-01-19Labeling · Supplement 4 · standard — Letter ↗AP
2004-06-04Labeling · Supplement 3 · standard — Label ↗AP
2002-12-31Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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