APPLICATION
ANDA201577
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-26
LATEST ACTION
2023-11-21
ROUTE
INTRACAVERNOUS, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BIVALIRUDINPrescription
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2023-11-21Labeling · Supplement 3 · standardAP
2019-10-01Labeling · Supplement 2 · 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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