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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021447
Company: LEGACY PHARMA USA

Products on NDA 021447

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021447

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2002	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21447lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21447ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-447_Zanaflex.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020397Orig1s029,021447Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020397Orig1s029,021447Orig1s017ltr.pdf
12/18/2020	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021447s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021447Orig1s015ltr.pdf
08/29/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
11/07/2013	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s011,020397Orig1s026ltr.pdf
03/08/2013	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021447Orig1s005ltr.pdf
07/28/2006	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020397s021, 021447s002LTR.pdf

Labels for NDA 021447

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/22/2024	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020397Orig1s029,021447Orig1s017lbl.pdf
12/18/2020	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021447s015lbl.pdf
11/07/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021447s011_020397s026lbl.pdf
07/28/2006	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020397s021,021447s002lbl.pdf
08/29/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21447lbl.pdf

Therapeutic Equivalents for NDA 021447

ZANAFLEX

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	210267	INGENUS PHARMS LLC
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	213798	RUBICON RESEARCH
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	210267	INGENUS PHARMS LLC
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	213798	RUBICON RESEARCH
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 4MG BASE	CAPSULE;ORAL	Prescription	No	AB	213365	SENORES PHARMS
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	210267	INGENUS PHARMS LLC
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	213798	RUBICON RESEARCH
TIZANIDINE HYDROCHLORIDE	TIZANIDINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE;ORAL	Prescription	No	AB	213365	SENORES PHARMS
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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