Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/07/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21345lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-345_Arixtra.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/11/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021345s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021345Orig1s035ltr.pdf
04/11/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/15/2014 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021345s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021345Orig1s032ltr.pdf
11/15/2013 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/12/2013 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021345s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021345Orig1s030ltr.pdf
12/23/2009 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s025ltr.pdf
03/26/2010 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021345s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021345s023ltr.pdf
08/14/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021345s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021345s019ltr.pdf
10/17/2008 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021345s018ltr.pdf
05/26/2005 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021345s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021345s010ltr.pdf
05/28/2004 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf
05/28/2004 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21345se1-004,005_arixtra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21345se1-004,005ltr.pdf
06/17/2003 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21345se1-002_arixtra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21345se1-002ltr.pdf
12/04/2002 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21345slr001_arixtra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21345slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

ARIXTRA

INJECTABLE;SUBCUTANEOUS; 2.5MG/0.5ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIXTRA FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE;SUBCUTANEOUS Prescription Yes AP 021345 MYLAN IRELAND LTD
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 2.5MG/0.5ML INJECTABLE;SUBCUTANEOUS Prescription No AP 091316 DR REDDYS LABS LTD

INJECTABLE;SUBCUTANEOUS; 5MG/0.4ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIXTRA FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE;SUBCUTANEOUS Prescription Yes AP 021345 MYLAN IRELAND LTD
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 5MG/0.4ML INJECTABLE;SUBCUTANEOUS Prescription No AP 091316 DR REDDYS LABS LTD

INJECTABLE;SUBCUTANEOUS; 7.5MG/0.6ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIXTRA FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE;SUBCUTANEOUS Prescription Yes AP 021345 MYLAN IRELAND LTD
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 7.5MG/0.6ML INJECTABLE;SUBCUTANEOUS Prescription No AP 091316 DR REDDYS LABS LTD

INJECTABLE;SUBCUTANEOUS; 10MG/0.8ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARIXTRA FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE;SUBCUTANEOUS Prescription Yes AP 021345 MYLAN IRELAND LTD
FONDAPARINUX SODIUM FONDAPARINUX SODIUM 10MG/0.8ML INJECTABLE;SUBCUTANEOUS Prescription No AP 091316 DR REDDYS LABS LTD

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English