APPLICATION
ANDA076286
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-03
LATEST ACTION
2020-10-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 2MG BASE · TABLET · ORAL
TIZANIDINE HYDROCHLORIDEPrescription
TIZANIDINE HYDROCHLORIDE EQ 4MG BASE · TABLET · ORAL
Approval history
2020-10-22Labeling · Supplement 15 · standardAP
2015-08-24Labeling · Supplement 12 · standardAP
2015-08-24Labeling · Supplement 11 · standardAP
2007-02-07Labeling · Supplement 9AP
2007-01-31Labeling · Supplement 8AP
2003-08-13Labeling · Supplement 4AP
2003-07-31Labeling · Supplement 1AP
2002-07-03OriginalAP
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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