APPLICATION
ANDA202471
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-01
LATEST ACTION
2019-09-23
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BIVALIRUDINPrescription
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2019-09-23Labeling · Supplement 3 · standardAP
2018-06-01UNKNOWN · 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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