Documents
Application Sponsors
BLA 761223 | GLAXOSMITHKLINE LLC | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 500MG/10ML | 0 | JEMPERLI | DOSTARLIMAB-GXLY |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-08-17 | PRIORITY |
Submissions Property Types
CDER Filings
GLAXOSMITHKLINE LLC
cder:Array
(
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[companyName] => GLAXOSMITHKLINE LLC
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[products] => [{"drugName":"JEMPERLI","activeIngredients":"DOSTARLIMAB-GXLY","strength":"500MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[supplements] =>
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