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Drugs@FDA: FDA-Approved Drugs

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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AXERT ALMOTRIPTAN MALATE EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
AXERT ALMOTRIPTAN MALATE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
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
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