FDA.reportPublic FDA data

Application 761174

Type
BLA
Sponsor
GLAXOSMITHKLINE

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0898JemperlidostarlimabGlaxoSmithKline LLCBLACurrent
0173-0898JemperlidostarlimabGlaxoSmithKline LLCBLACurrent
0173-0898JemperlidostarlimabGlaxoSmithKline LLCBLACurrent
0173-0898JemperlidostarlimabGlaxoSmithKline LLCBLACurrent
0173-0898JemperlidostarlimabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85556SUPPL 2026-03-30
79291SUPPL 2024-08-02
79290SUPPL 2024-08-02
77787SUPPL 2024-03-12
77765SUPPL 2024-03-08
74968SUPPL 2023-08-01
74963SUPPL 2023-07-31
73452SUPPL 2023-02-10
73451SUPPL 2023-02-10
73442SUPPL 2023-02-09
73441SUPPL 2023-02-09
70884SUPPL2022-05-02
70853SUPPL2022-04-29
70852SUPPL2022-04-29
67570ORIG2021-05-21
67172ORIG2021-04-26
67144ORIG2021-04-22
67141ORIG2021-04-22