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FDA BLA · BLA761174

JEMPERLI

dostarlimab

Sponsor: GLAXOSMITHKLINE

APPLICATION
BLA761174
TYPE
BLA
ORIGINAL APPROVAL
2021-04-22
LATEST ACTION
2024-08-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

JEMPERLIPrescription
DOSTARLIMAB-GXLY 500MG/10ML · INJECTABLE · INJECTION

Approval history

2024-08-01Efficacy · Supplement 9 · priority — Label ↗AP
2024-03-06Labeling · Supplement 10 · standard — Label ↗AP
2023-07-31Efficacy · Supplement 6 · priority — Label ↗AP
2023-02-09Efficacy · Supplement 4 · standard — Label ↗AP
2023-02-09Efficacy · Supplement 3 · standard — Label ↗AP
2022-04-28Labeling · Supplement 2 · standard — Label ↗AP
2021-04-22Type 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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