APPLICATION
ANDA076416
TYPE
ANDA
ORIGINAL APPROVAL
2003-09-29
LATEST ACTION
2014-12-14
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
2014-12-14Labeling · Supplement 13 · standardAP
2007-09-25Labeling · Supplement 4AP
2007-03-22Labeling · Supplement 3AP
2003-09-29OriginalAP
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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