APPLICATION
ANDA091468
TYPE
ANDA
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
None (Tentative Approval)
Products
BIVALIRUDINNone (Tentative Approval)
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INJECTION
Approval history
2017-02-02OriginalTA
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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