Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125469
Company: ELI LILLY AND CO
Company: ELI LILLY AND CO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRULICITY | DULAGLUTIDE | 0.75MG/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
TRULICITY | DULAGLUTIDE | 1.5MG/0.5ML | INJECTABLE;INJECTION | Prescription | None | TBD | No |
TRULICITY | DULAGLUTIDE | 3MG/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
TRULICITY | DULAGLUTIDE | 4.5MG/0.5ML | INJECTABLE;INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/18/2014 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2022 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf | |
11/17/2022 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s051ltr.pdf | |
06/10/2022 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf | |
09/30/2021 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125469Orig1s044ltr.pdf | |
09/03/2020 | SUPPL-36 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s036ltr.pdf | |
02/21/2020 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s033ltr.pdf | |
09/21/2018 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s024ltr.pdf | |
01/15/2019 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125469Orig1s023ltr.pdf | |
12/12/2017 | SUPPL-21 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s021ltr.pdf |
06/29/2018 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s017ltr.pdf | |
08/01/2017 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf | |
08/01/2017 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf | |
01/27/2017 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf | |
01/27/2017 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf | |
07/27/2015 | SUPPL-4 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf |
12/19/2014 | SUPPL-2 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf |
03/09/2015 | SUPPL-1 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/17/2022 | SUPPL-51 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf | |
06/10/2022 | SUPPL-52 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf | |
06/10/2022 | SUPPL-52 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf | |
06/10/2022 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf | |
09/30/2021 | SUPPL-44 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf | |
09/03/2020 | SUPPL-36 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf | |
02/21/2020 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf | |
01/15/2019 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf | |
09/21/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf | |
06/29/2018 | SUPPL-17 | Efficacy-Accelerated Approval Confirmatory Study | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf | |
08/01/2017 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf | |
08/01/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf | |
01/27/2017 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf | |
01/27/2017 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf | |
09/18/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf |