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FDA BLA · BLA761025

PRAXBIND

idarucizumab

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
BLA761025
TYPE
BLA
ORIGINAL APPROVAL
2015-10-16
LATEST ACTION
2022-02-11
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PRAXBINDPrescription
IDARUCIZUMAB 2.5G/50ML · INJECTABLE · INJECTION

Approval history

2022-02-11Labeling · Supplement 13 · standard — Label ↗AP
2018-04-12Efficacy · Supplement 2 · standard — Label ↗AP
2015-10-16Type 1 - New Molecular Entity · Original · priority — Label ↗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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