APPLICATION
NDA020397
TYPE
NDA
ORIGINAL APPROVAL
1996-11-27
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
ZANAFLEX · ReferenceDiscontinued
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZANAFLEX · ReferencePrescription
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
Approval history
2016-05-27Manufacturing (CMC) · Supplement 25 · standardAP
2002-05-17Manufacturing (CMC) · Supplement 16 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 15 · standardAP
2001-08-22Manufacturing (CMC) · Supplement 13 · standardAP
2001-08-21Manufacturing (CMC) · Supplement 12 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 11 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 10 · standardAP
2000-08-21Manufacturing (CMC) · Supplement 8 · standardAP
2000-06-26Manufacturing (CMC) · Supplement 7 · standardAP
1999-06-15Manufacturing (CMC) · Supplement 5 · standardAP
1997-10-23Manufacturing (CMC) · Supplement 3 · standardAP
1997-09-02Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-02Manufacturing (CMC) · Supplement 2 · standardAP
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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