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FDA NDA · NDA208374

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA208374
TYPE
NDA
ORIGINAL APPROVAL
2017-12-21
LATEST ACTION
2021-01-08
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE · ReferenceDiscontinued
BIVALIRUDIN 250MG/50ML (5MG/ML) · SOLUTION · INTRAVENOUS
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE · ReferenceDiscontinued
BIVALIRUDIN 500MG/100ML (5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-01-08Labeling · Supplement 2 · standard — Label ↗AP
2017-12-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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