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FDA NDA · NDA209552

ARGATROBAN

Sponsor: EUGIA PHARMA SPECLTS

APPLICATION
NDA209552
TYPE
NDA
ORIGINAL APPROVAL
2018-11-27
LATEST ACTION
2026-06-10
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ARGATROBAN IN SODIUM CHLORIDEPrescription
ARGATROBAN 50MG/50ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-10Labeling · Supplement 8 · standardLetterAP
2018-11-27Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
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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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