APPLICATION
BLA761223
TYPE
BLA
ORIGINAL APPROVAL
2021-08-17
LATEST ACTION
2021-08-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
JEMPERLIPrescription
DOSTARLIMAB-GXLY 500MG/10ML · INJECTABLE · INJECTION
Approval history
2021-08-17Type 9 - New indication submitted as distinct BLA, consolidated · Original · priority — 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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