APPLICATION
ANDA078868
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-03
LATEST ACTION
2025-12-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 6MG BASE · CAPSULE · ORAL
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE · CAPSULE · ORAL
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · CAPSULE · ORAL
Approval history
2025-12-16Labeling · Supplement 7 · standardAP
2022-05-25Labeling · Supplement 4 · standardAP
2016-02-23Labeling · Supplement 1 · 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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