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FDA NDA · NDA211215

BIVALIRUDIN

Sponsor: MAIA PHARMS INC

APPLICATION
NDA211215
TYPE
NDA
ORIGINAL APPROVAL
2019-07-25
LATEST ACTION
2023-05-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ANGIOMAX RTU · ReferencePrescription
BIVALIRUDIN 250MG/50ML (5MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-05-09Labeling · Supplement 2 · standard — Letter ↗AP
2019-07-25Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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