Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021345
Company: MYLAN IRELAND LTD
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 |