← FDA DRUG APPROVALS

FDA ANDA · ANDA206918

FONDAPARINUX SODIUM

Sponsor: EUGIA PHARMA

APPLICATION
ANDA206918
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-26
LATEST ACTION
2017-12-26
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

2017-12-26UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →