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FDA ANDA · ANDA206551

BIVALIRUDIN

Sponsor: ACCORD HLTHCARE

APPLICATION
ANDA206551
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-22
LATEST ACTION
2025-02-18
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BIVALIRUDINPrescription
BIVALIRUDIN 250MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2025-02-18Labeling · Supplement 2 · standardAP
2025-02-18Labeling · Supplement 7 · standardAP
2025-02-18Labeling · Supplement 5 · standardAP
2017-11-22UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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