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FDA ANDA · ANDA076282

TIZANIDINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA076282
TYPE
ANDA
ORIGINAL APPROVAL
2003-12-16
LATEST ACTION
2020-10-22
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

2020-10-22Labeling · Supplement 4 · standardAP
2008-04-28Labeling · Supplement 2AP
2003-12-16OriginalAP
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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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