← FDA DRUG APPROVALS

FDA ANDA · ANDA076284

TIZANIDINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA076284
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-03
LATEST ACTION
2002-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TIZANIDINE HYDROCHLORIDEDiscontinued
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
TIZANIDINE HYDROCHLORIDEDiscontinued
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL

Approval history

2002-11-18Labeling · Supplement 2AP
2002-07-03OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →