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FDA NDA · NDA204958

KENGREAL

cangrelor

Sponsor: CHIESI

APPLICATION
NDA204958
TYPE
NDA
ORIGINAL APPROVAL
2015-06-22
LATEST ACTION
2023-01-26
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

KENGREAL · ReferencePrescription
CANGRELOR 50MG/VIAL · POWDER · INTRAVENOUS

Approval history

2023-01-26Labeling · Supplement 3 · standard — Letter ↗AP
2019-10-23Labeling · Supplement 2 · standard — Letter ↗AP
2016-03-02Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2015-06-22Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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