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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209605
Company: JUBILANT GENERICS

Products on ANDA 209605

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209605

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209605

TIZANIDINE HYDROCHLORIDE

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	213223	ALEMBIC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	212196	ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	078868	APOTEX INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	213544	AUROBINDO PHARMA LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	210021	CADILA PHARMS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	209605	JUBILANT GENERICS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	210267	NOVAST LABS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	213798	RUBICON
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	No	AB	208622	ZYDUS PHARMS
ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 2MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021447	LEGACY PHARMA USA

CAPSULE;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	CAPSULE;ORAL	Prescription	No	AB	213223	ALEMBIC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	212196	ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	078868	APOTEX INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	213544	AUROBINDO PHARMA LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	210021	CADILA PHARMS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	209605	JUBILANT GENERICS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	210267	NOVAST LABS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	213798	RUBICON
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	208622	ZYDUS PHARMS
ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021447	LEGACY PHARMA USA

CAPSULE;ORAL; EQ 6MG 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 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	213223	ALEMBIC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	212196	ALKEM LABS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	078868	APOTEX INC
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	213544	AUROBINDO PHARMA LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	210021	CADILA PHARMS LTD
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	209605	JUBILANT GENERICS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	210267	NOVAST LABS
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	213798	RUBICON
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	208622	ZYDUS PHARMS
ZANAFLEX	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	021447	LEGACY PHARMA USA

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