Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021641
Company: TEVA
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

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 201950 APOTEX INC
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201971 MYLAN PHARMS INC
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201970 ORCHID HLTHCARE
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201823 WATSON LABS INC

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 201950 APOTEX INC
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201971 MYLAN PHARMS INC
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201970 ORCHID HLTHCARE
RASAGILINE MESYLATE RASAGILINE MESYLATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201823 WATSON LABS INC

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