APPLICATION
BLA761429
TYPE
BLA
ORIGINAL APPROVAL
2024-12-27
LATEST ACTION
2024-12-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
OPDIVO QVANTIGPrescription
NIVOLUMAB 600MG, HYALURONIDASE-NVHY 10000 UNITS PER 5ML(120MG/2000UNITS PER ML) · INJECTABLE · INJECTION
Approval history
2024-12-27Type 9 - New indication submitted as distinct BLA, consolidated · Original · standard — Label ↗AP
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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