← FDA DRUG APPROVALS

FDA NDA · NDA021447

ZANAFLEX

tizanidine hydrochloride

Sponsor: LEGACY

APPLICATION
NDA021447
TYPE
NDA
ORIGINAL APPROVAL
2002-08-29
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZANAFLEX · ReferencePrescription
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · CAPSULE · ORAL
ZANAFLEX · ReferencePrescription
TIZANIDINE HYDROCHLORIDE EQ 6MG BASE · CAPSULE · ORAL
ZANAFLEX · ReferencePrescription
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL

Approval history

2024-11-22Labeling · Supplement 17 · standard — Label ↗AP
2020-12-18Labeling · Supplement 15 · standard — Letter ↗AP
2014-08-29Manufacturing (CMC) · Supplement 12 · standardAP
2013-11-07Labeling · Supplement 11 · unknown — Label ↗AP
2013-03-08Labeling · Supplement 5 · standard — Letter ↗AP
2006-07-28Labeling · Supplement 2 · standard — Letter ↗AP
2002-08-29Type 3 - New Dosage Form · Original · standard — Label ↗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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