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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021641
Company: TEVA

Summary Review

Products on NDA 021641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AZILECT	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	AB	Yes	No
AZILECT	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021641

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2006	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021641lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021641s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021641s000_AzilectTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2020	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021641s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021641Orig1s021ltr.pdf
12/20/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021641s020lbl.pdf
12/09/2015	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/20/2015	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
05/29/2014	SUPPL-17	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf
05/29/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021641Orig2s016,s017ltr.pdf
12/09/2009	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf
12/09/2009	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021641S008_SumR.pdf
12/09/2009	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf
12/09/2009	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf
12/09/2009	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf
12/09/2009	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf
12/09/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021641s002s003s004s005s006s007s008s010ltr.pdf

Labels for NDA 021641

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021641s021lbl.pdf
12/20/2018	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021641s020lbl.pdf
05/29/2014	SUPPL-17	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf
05/29/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021641s016s017lbl.pdf
12/09/2009	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
12/09/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021641s002s003s004s005s007s008s010lbl.pdf
05/16/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021641lbl.pdf

Therapeutic Equivalents for NDA 021641

AZILECT

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILECT	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021641	TEVA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201889	ALKEM LABS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201971	AUROBINDO PHARMA USA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	206153	INDOCO
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	207004	MICRO LABS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201970	ORBION PHARMS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	218163	SKG PHARMA

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILECT	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	021641	TEVA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201889	ALKEM LABS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201971	AUROBINDO PHARMA USA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	206153	INDOCO
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	207004	MICRO LABS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201970	ORBION PHARMS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218163	SKG PHARMA

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