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 |
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 |
|---|---|---|---|---|---|
| 12/23/2024 | SUPPL-52 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021345s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021345Orig1s052ltr.pdf | |
| 08/25/2020 | SUPPL-43 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021345Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021345Orig1s043ltr.pdf | |
| 12/13/2019 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021345s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021345Orig1s037ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/23/2024 | SUPPL-52 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021345s052lbl.pdf | |
| 08/25/2020 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021345Orig1s043lbl.pdf | |
| 08/25/2020 | SUPPL-43 | Labeling-Container/Carton Labels | 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 |
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 | 218312 | BRIGHTGENE |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 091316 | DR REDDYS LABS LTD |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 216493 | HANGZHOU ZHONGMEI |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
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 |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 216493 | HANGZHOU ZHONGMEI |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
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 |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 216493 | HANGZHOU ZHONGMEI |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |
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 |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206918 | EUGIA PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 216493 | HANGZHOU ZHONGMEI |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 206812 | HENGRUI PHARMA |
| FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE;SUBCUTANEOUS | Prescription | No | AP | 208615 | SCINOPHARM TAIWAN |