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FDA ANDA · ANDA076371

TIZANIDINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA076371
TYPE
ANDA
ORIGINAL APPROVAL
2003-04-09
LATEST ACTION
2020-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-10-30Labeling · Supplement 3 · standardAP
2004-04-09Labeling · Supplement 1AP
2003-04-09OriginalAP
VIEW ON DRUGS@FDA ↗

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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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