APPLICATION
ANDA076354
TYPE
ANDA
ORIGINAL APPROVAL
2003-03-28
LATEST ACTION
2014-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
Approval history
2014-12-13Labeling · Supplement 9 · standardAP
2014-12-13Labeling · Supplement 10 · standardAP
2010-03-22Labeling · Supplement 6AP
2008-11-14Labeling · Supplement 5AP
2003-03-28OriginalAP
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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