APPLICATION
ANDA212196
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-27
LATEST ACTION
2025-09-30
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
2025-09-30Labeling · Supplement 3 · standardAP
2022-06-10Labeling · Supplement 1 · standardAP
2019-03-27UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.