APPLICATION
ANDA091316
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-11
LATEST ACTION
2016-02-18
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
2016-02-18Labeling · Supplement 3 · standardAP
2014-03-19Labeling · Supplement 2 · 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.
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