APPLICATION
ANDA204876
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-06
LATEST ACTION
2020-09-17
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BIVALIRUDINDiscontinued
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2020-09-17Labeling · Supplement 1 · standardAP
2020-09-17Labeling · 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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