FDA.reportPublic FDA data

Application 761035

Type
BLA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

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

NDC Listings For This Application#

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