# ARIXTRA
> **NDA021345** · New Drug Application · Sponsor: MYLAN IRELAND LTD · Approved 2001-12-07
## Drug
- **FDA Application Number:** NDA021345
- **Application type:** New Drug Application
- **Brand name:** ARIXTRA
- **Generic name:** FONDAPARINUX SODIUM
- **Active ingredients:** FONDAPARINUX SODIUM
- **Dosage form:** SOLUTION
- **Route:** SUBCUTANEOUS
- **Marketing status:** Prescription
- **Sponsor:** MYLAN IRELAND LTD
- **Manufacturer:** Mylan Institutional LLC
- **First approval:** 2001-12-07
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021345)
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