Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021001
Company: JANSSEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AXERT ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription AB Yes No
AXERT ALMOTRIPTAN MALATE EQ 12.5MG 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
05/07/2001 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021001s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021001Orig1s015ltr.pdf
08/07/2014 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021001Orig1s014ltr.pdf
04/30/2009 SUPPL-11 Efficacy-New Patient Population Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf
04/30/2009 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s010,s011ltr.pdf
03/27/2009 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf
03/27/2009 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021001s008,s009ltr.pdf
06/01/2004 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21001slr002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/15/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021001s015lbl.pdf
08/07/2014 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021001s014lbl.pdf
04/30/2009 SUPPL-11 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf
04/30/2009 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s010s011lbl.pdf
03/27/2009 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf
03/27/2009 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021001s008s009lbl.pdf
05/07/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21001_Axert_prntlbl.pdf

AXERT

TABLET;ORAL; EQ 6.25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 205523 AJANTA PHARMA LTD
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 205171 MYLAN PHARMS INC
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription No AB 078027 TEVA PHARMS USA
AXERT ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET;ORAL Prescription Yes AB 021001 JANSSEN PHARMS

TABLET;ORAL; EQ 12.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 205523 AJANTA PHARMA LTD
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 205171 MYLAN PHARMS INC
ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription No AB 078027 TEVA PHARMS USA
AXERT ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET;ORAL Prescription Yes AB 021001 JANSSEN PHARMS

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