Documents
Application Sponsors
| BLA 761035 | BRISTOL MYERS SQUIBB | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 300MG | 0 | EMPLICITI | ELOTUZUMAB |
| 002 | INJECTABLE;INJECTION | 400MG | 0 | EMPLICITI | ELOTUZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-11-30 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2017-05-11 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2018-11-06 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2019-10-28 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2022-03-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 30 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 15 | Null | 6 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 761035
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"EMPLICITI","activeIngredients":"ELOTUZUMAB","strength":"300MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"EMPLICITI","activeIngredients":"ELOTUZUMAB","strength":"400MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/28\/2019","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761035s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2018","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761035s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2017","submission":"SUPPL-5","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761035s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761035s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/30\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/761035s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/761035Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/761035Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/761035Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/28\/2019","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761035s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761035Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"11\/06\/2018","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761035s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761035Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/11\/2017","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761035s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761035Orig1s005ltr.pdf\"}]","notes":">"}]
[actionDate] => 2019-10-28
)
)