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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076347
Company: EPIC PHARMA LLC

Products on ANDA 076347

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 076347

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/11/2002	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
07/18/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/10/2007	SUPPL-6	Labeling		Label is not available on this site.
03/02/2007	SUPPL-5	Labeling		Label is not available on this site.
01/12/2007	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076347

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	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	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

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