APPLICATION
ANDA208615
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-14
LATEST ACTION
2023-09-12
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FONDAPARINUX SODIUMPrescription
FONDAPARINUX SODIUM 10MG/0.8ML (10MG/0.8ML) · SOLUTION · SUBCUTANEOUS
FONDAPARINUX SODIUMPrescription
FONDAPARINUX SODIUM 5MG/0.4ML (5MG/0.4ML) · SOLUTION · SUBCUTANEOUS
FONDAPARINUX SODIUMPrescription
FONDAPARINUX SODIUM 7.5MG/0.6ML (7.5MG/0.6ML) · SOLUTION · SUBCUTANEOUS
FONDAPARINUX SODIUMPrescription
FONDAPARINUX SODIUM 2.5MG/0.5ML (2.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
Approval history
2023-09-12Labeling · Supplement 3 · standardAP
2018-11-14UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.