APPLICATION
ANDA210267
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-12
LATEST ACTION
2025-09-29
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
2025-09-29Labeling · Supplement 4 · standardAP
2022-05-27Labeling · Supplement 2 · standardAP
2019-03-12UNKNOWN · Original · 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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