← FDA Drug Approvals (Drugs@FDA)
ARIXTRA
NDA · New Drug Application · Sponsor: MYLAN IRELAND LTD · Approved 2001-12-07
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown