Application 761223

Type
BLA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JEMPERLIDOSTARLIMAB-GXLYINJECTABLE;INJECTION500MG/10MLNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JemperliDOSTARLIMABGlaxoSmithKline LLC095eab9f-545a-4f12-bfb7-19477fb901a52025-09-02Warnings, Adverse reactionsName fallback
brand name: Jemperli

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68471ORIG2021-08-26
68403ORIG2021-08-18
68396ORIG2021-08-17
68395ORIG2021-08-17