FDA.reportPublic FDA data

Application 761035

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761035Emplicitielotuzumab351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMPLICITIELOTUZUMABINJECTABLE;INJECTION300MGNoNo
002EMPLICITIELOTUZUMABINJECTABLE;INJECTION400MGNoNo

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMPLICITIELOTUZUMABE.R. Squibb & Sons, L.L.C.80686b7e-f6f4-4154-b5c0-c846425e2d912022-03-22Warnings, Adverse reactionsExact identifier
application number: BLA761035
ndc (product): 0003-2291
ndc (product): 0003-4522

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-2291EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent
0003-4522EMPLICITIelotuzumabE.R. Squibb & Sons, L.L.C.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70616SUPPL2022-03-28
70587SUPPL2022-03-23
60707SUPPL2019-10-29
60700SUPPL2019-10-29
56479SUPPL2018-11-15
56365SUPPL2018-11-08
48380SUPPL2017-05-15
48356SUPPL2017-05-12
43553ORIG2016-01-07
24539ORIG2015-12-01
40640ORIG2015-11-30
10663ORIG2015-11-30