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FDA BLA · BLA761128

ADAKVEO

crizanlizumab

Sponsor: NOVARTIS PHARMS CORP

APPLICATION
BLA761128
TYPE
BLA
ORIGINAL APPROVAL
2019-11-15
LATEST ACTION
2024-06-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ADAKVEOPrescription
CRIZANLIZUMAB-TMCA 100MG/10ML · INJECTABLE · INJECTION

Approval history

2024-06-26Efficacy · Supplement 6 · standard — Letter ↗AP
2022-09-08Labeling · Supplement 5 · standard — Letter ↗AP
2021-07-12Labeling · Supplement 1 · standard — Letter ↗AP
2019-11-15Type 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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