APPLICATION
ANDA213078
TYPE
ANDA
ORIGINAL APPROVAL
2021-05-28
LATEST ACTION
2021-05-28
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BIVALIRUDINPrescription
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2021-05-28UNKNOWN · Original · 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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