← FDA DRUG APPROVALS

FDA NDA · NDA021345

ARIXTRA

fondaparinux sodium

Sponsor: MYLAN IRELAND LTD

APPLICATION
NDA021345
TYPE
NDA
ORIGINAL APPROVAL
2001-12-07
LATEST ACTION
2024-12-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ARIXTRA · ReferencePrescription
FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) · SOLUTION · SUBCUTANEOUS
ARIXTRA · ReferencePrescription
FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
ARIXTRA · ReferencePrescription
FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) · SOLUTION · SUBCUTANEOUS
ARIXTRA · ReferencePrescription
FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) · SOLUTION · SUBCUTANEOUS

Approval history

2024-12-23Efficacy · Supplement 52 · standard — Label ↗AP
2020-08-25Labeling · Supplement 43 · standard — Letter ↗AP
2019-12-13Labeling · Supplement 37 · standard — Label ↗AP
2017-08-11Labeling · Supplement 35 · standard — Label ↗AP
2016-04-11Manufacturing (CMC) · Supplement 33 · priorityAP
2014-07-15Labeling · Supplement 32 · standard — Label ↗AP
2013-11-15Manufacturing (CMC) · Supplement 31 · priorityAP
2013-09-12Labeling · Supplement 30 · standard — Label ↗AP
2010-03-26Labeling · Supplement 23 · unknown — Label ↗AP
2009-12-23Labeling · Supplement 25 · unknown — Label ↗AP
2009-08-14Labeling · Supplement 19 · standard — Label ↗AP
2008-10-17Labeling · Supplement 18 · standard — Letter ↗AP
2005-05-26Efficacy · Supplement 10 · unknown — Label ↗AP
2004-05-28Efficacy · Supplement 4 · unknown — Label ↗AP
2004-05-28Efficacy · Supplement 5 · unknown — Letter ↗AP
2003-06-17Efficacy · Supplement 2 · priority — Label ↗AP
2002-12-04Labeling · Supplement 1 · standard — Label ↗AP
2001-12-07Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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