APPLICATION
ANDA202626
TYPE
ANDA
ORIGINAL APPROVAL
2014-06-30
LATEST ACTION
2023-08-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ARGATROBANPrescription
ARGATROBAN 250MG/2.5ML (100MG/ML) · INJECTABLE · INJECTION
Approval history
2023-08-01Labeling · Supplement 3 · standardAP
2023-08-01Labeling · Supplement 6 · standardAP
2014-06-30UNKNOWN · OriginalAP
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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