Home Applications 761035 Application 761035
Type BLA
Sponsor BRISTOL MYERS SQUIBB Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761035 Empliciti elotuzumab 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMPLICITI ELOTUZUMAB INJECTABLE;INJECTION 300MG No No 002 EMPLICITI ELOTUZUMAB INJECTABLE;INJECTION 400MG No No
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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-2291 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current 0003-4522 EMPLICITI elotuzumab E.R. Squibb & Sons, L.L.C. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 70616 SUPPL 2022-03-28 70587 SUPPL 2022-03-23 60707 SUPPL 2019-10-29 60700 SUPPL 2019-10-29 56479 SUPPL 2018-11-15 56365 SUPPL 2018-11-08 48380 SUPPL 2017-05-15 48356 SUPPL 2017-05-12 43553 ORIG 2016-01-07 24539 ORIG 2015-12-01 40640 ORIG 2015-11-30 10663 ORIG 2015-11-30