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FDA ANDA · ANDA076280

TIZANIDINE HYDROCHLORIDE

Sponsor: CHARTWELL RX

APPLICATION
ANDA076280
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-27
LATEST ACTION
2016-02-20
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

2016-02-20Labeling · Supplement 20 · standardAP
2014-01-29Labeling · Supplement 14AP
2005-08-15Labeling · Supplement 10AP
2005-04-28Labeling · Supplement 7AP
2003-07-31Labeling · Supplement 1AP
2002-06-27OriginalAP
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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