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FDA BLA · BLA761062

EVENITY

Sponsor: AMGEN INC

APPLICATION
BLA761062
TYPE
BLA
ORIGINAL APPROVAL
2019-04-09
LATEST ACTION
2019-12-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EVENITYPrescription
ROMOSOZUMAB-AQQG 105MG/1.17ML · INJECTABLE · INJECTION

Approval history

2019-12-20Labeling · Supplement 2 · standardLabelAP
2019-04-09Type 1 - New Molecular Entity · Original · standardLabelAP
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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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