Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076533
Company: APOTEX

Products on ANDA 076533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	AB	No	No
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/16/2004	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/03/2025	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/17/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/28/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
04/02/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076533

TIZANIDINE HYDROCHLORIDE

TABLET;ORAL; EQ 2MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	211798	ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	076533	APOTEX
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	208187	CADILA
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	076286	DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	076347	EPIC PHARMA LLC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	218920	GRAVITI PHARMS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	076281	OXFORD PHARMS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	076416	SUN PHARM INDS INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	TABLET;ORAL	Prescription	No	AB	091283	UNICHEM LABS LTD

TABLET;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	211798	ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076533	APOTEX
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	208187	CADILA
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076286	DR REDDYS LABS INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076347	EPIC PHARMA LLC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	218920	GRAVITI PHARMS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076281	OXFORD PHARMS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	076416	SUN PHARM INDS INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	No	AB	091283	UNICHEM LABS LTD
ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	TABLET;ORAL	Prescription	Yes	AB	020397	LEGACY PHARMA USA