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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021345
Company: MYLAN IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARIXTRA FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
ARIXTRA FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
ARIXTRA FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
ARIXTRA FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE;SUBCUTANEOUS Prescription AP Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/25/2020 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021345Orig1s043lbl.pdf
08/25/2020 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021345Orig1s043lbl.pdf
12/13/2019 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021345s037lbl.pdf
08/11/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021345s035lbl.pdf
07/15/2014 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021345s032lbl.pdf
09/12/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021345s030lbl.pdf
03/26/2010 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf
12/23/2009 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s025lbl.pdf
08/14/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf
05/26/2005 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021345s010lbl.pdf
05/28/2004 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf
05/28/2004 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf
06/17/2003 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21345se1-002_arixtra_lbl.pdf
12/04/2002 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21345slr001_arixtra_lbl.pdf
12/07/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21345lbl.pdf
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