FDA.reportPublic FDA data

Application 761158

Type
BLA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BLENREPBELANTAMAB MAFODOTIN-BLMFINJECTABLE;INTRAVENOUS2.5MG/KGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent
0173-0896BlenrepBelantamabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70339SUPPL2022-03-01
70338SUPPL2022-03-01
70314SUPPL2022-03-01
69513SUPPL2021-12-08
65310SUPPL2020-11-25
64469ORIG2020-09-01
64241ORIG2020-08-10
64208ORIG2020-08-06
64207ORIG2020-08-06