APPLICATION
ANDA091283
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-28
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 18 · standardAP
2024-11-27Labeling · Supplement 16 · standardAP
2017-09-29Labeling · Supplement 4 · standardAP
2012-11-28OriginalAP
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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