Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125469
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
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
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
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

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