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FDA BLA · BLA761033

CINQAIR

reslizumab

Sponsor: TEVA RESPIRATORY LLC

APPLICATION
BLA761033
TYPE
BLA
ORIGINAL APPROVAL
2016-03-23
LATEST ACTION
2019-01-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CINQAIRPrescription
RESLIZUMAB 100MG/10ML · INJECTABLE · INJECTION

Approval history

2019-01-09Labeling · Supplement 10 · standardLabelAP
2016-03-23Type 1 - New Molecular Entity · Original · standardSummary ReviewAP
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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