APPLICATION
ANDA090811
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-14
LATEST ACTION
2019-11-22
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BIVALIRUDINDiscontinued
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS
Approval history
2019-11-22Labeling · Supplement 10 · standardAP
2019-11-22Labeling · Supplement 5 · standardAP
2019-11-22Labeling · Supplement 3 · standardAP
2019-11-22Labeling · Supplement 8 · 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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