Documents
Application Sponsors
| BLA 125469 | ELI LILLY AND CO | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.75MG/0.5ML | 0 | TRULICITY | DULAGLUTIDE |
| 002 | INJECTABLE;INJECTION | 1.5MG/0.5ML | 2 | TRULICITY | DULAGLUTIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-09-18 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-12-19 | STANDARD |
| REMS; REMS | SUPPL | 4 | AP | 2015-07-27 | N/A |
| EFFICACY; Efficacy | SUPPL | 7 | AP | 2017-01-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2017-01-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2017-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2017-08-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2018-06-29 | STANDARD |
| REMS; REMS | SUPPL | 21 | AP | 2017-12-12 | N/A |
| EFFICACY; Efficacy | SUPPL | 23 | AP | 2019-01-15 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2018-09-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2020-02-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2020-09-03 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2021-09-30 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2022-06-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 51 | AP | 2022-11-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 2022-06-10 | 901 REQUIRED |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 4 | Null | 6 |
| SUPPL | 7 | Null | 33 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 11 | Null | 6 |
| SUPPL | 13 | Null | 6 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 33 | Null | 7 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 44 | Null | 15 |
| SUPPL | 46 | Null | 7 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 6 |
CDER Filings
ELI LILLY AND CO
cder:Array
(
[0] => Array
(
[ApplNo] => 125469
[companyName] => ELI LILLY AND CO
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125469s033lbl.pdf#page=26"]
[products] => [{"drugName":"TRULICITY","activeIngredients":"DULAGLUTIDE","strength":"0.75MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"TRULICITY","activeIngredients":"DULAGLUTIDE","strength":"1.5MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
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[originalApprovals] => [{"actionDate":"09\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125469Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125469Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125469Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125469Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125469s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125469Orig1s033ltr.pdf\"}]","notes":">"},{"actionDate":"09\/21\/2018","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125469s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125469Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"01\/15\/2019","submission":"SUPPL-23","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125469s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125469Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"12\/12\/2017","submission":"SUPPL-21","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125469Orig1s021ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/29\/2018","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125469s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125469Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2017","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125469s011s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125469Orig1s011,125469Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2017","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125469s011s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125469Orig1s011,125469Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125469s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125469Orig1s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2017","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125469s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125469Orig1s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2015","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125469Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2014","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125469Orig1s002ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"03\/09\/2015","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125469Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-02-21
)
)