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FDA ANDA · ANDA076347

TIZANIDINE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA076347
TYPE
ANDA
ORIGINAL APPROVAL
2002-10-11
LATEST ACTION
2016-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2016-07-18Labeling · Supplement 8 · standardAP
2007-04-10Labeling · Supplement 6AP
2007-03-02Labeling · Supplement 5AP
2007-01-12Labeling · Supplement 4AP
2002-10-11OriginalAP
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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