`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`Biologic License Application (BLA): 125469
`Company: ELI LILLY AND CO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=125469)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf#page=16)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf)
`
`Products on BLA 125469
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`TRULICITY
`
`TRULICITY
`
`DULAGLUTIDE
`
`DULAGLUTIDE
`
`Showing 1 to 2 of 2 entries
`
`0.75MG/0.5ML
`
`INJECTABLE;INJECTION
`
`1.5MG/0.5ML
`
`INJECTABLE;INJECTION
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`No
`
`TBD
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 125469
`
`RS
`
`No
`
`No
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`09/18/2014
`
`ORIG-1
`
`Approval
`
`Review
`Priority;
`Orphan
`Status
`
`N/A
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000Lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`11/17/2022
`
`SUPPL-51
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s051ltr.pdf)
`
`06/10/2022
`
`SUPPL-52
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf)
`
`06/10/2022
`
`SUPPL-46
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125469Orig1s046, s052ltr.pdf)
`
`09/30/2021
`
`SUPPL-44
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125469Orig1s044ltr.pdf)
`
`09/03/2020
`
`SUPPL-36
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s036ltr.pdf)
`
`02/21/2020
`
`SUPPL-33
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125469Orig1s033ltr.pdf)
`
`01/15/2019
`
`SUPPL-23
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125469Orig1s023ltr.pdf)
`
`Novo Nordisk Exhibit 2447
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`09/21/2018
`
`SUPPL-24
`
`Supplement
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s024ltr.pdf)
`
`06/29/2018
`
`SUPPL-17
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125469Orig1s017ltr.pdf)
`
`12/12/2017
`
`SUPPL-21
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s021ltr.pdf)
`
`08/01/2017
`
`SUPPL-13
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf)
`
`08/01/2017
`
`SUPPL-11
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s011,125469Orig1s013ltr.pdf)
`
`01/27/2017
`
`SUPPL-8
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf)
`
`01/27/2017
`
`SUPPL-7
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125469Orig1s007,s008ltr.pdf)
`
`07/27/2015
`
`SUPPL-4
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s004ltr.pdf)
`
`03/09/2015
`
`SUPPL-1
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125469Orig1s001ltr.pdf)
`
`12/19/2014
`
`SUPPL-2
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125469Orig1s002ltr.pdf)
`
`Showing 1 to 17 of 17 entries
`
`Labels for BLA 125469
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2447
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`Biologic License Application (BLA): 125469
`Company: ELI LILLY AND CO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=125469)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf#page=16)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125469Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on BLA 125469
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 125469
`
`Labels for BLA 125469
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`11/17/2022
`
`SUPPL-51
`
`06/10/2022
`
`SUPPL-52
`
`06/10/2022
`
`SUPPL-52
`
`06/10/2022
`
`SUPPL-46
`
`09/30/2021
`
`SUPPL-44
`
`09/03/2020
`
`SUPPL-36
`
`02/21/2020
`
`SUPPL-33
`
`01/15/2019
`
`SUPPL-23
`
`09/21/2018
`
`SUPPL-24
`
`06/29/2018
`
`SUPPL-17
`
`08/01/2017
`
`SUPPL-13
`
`08/01/2017
`
`SUPPL-11
`
`01/27/2017
`
`SUPPL-8
`
`01/27/2017
`
`SUPPL-7
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-New Patient
`Population
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New Dosing
`Regimen
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`E cacy-Accelerated
`Approval
`Con rmatory Study
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-New
`Indication
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s051lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125469s046s052lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125469s044lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125469s033lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125469s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s024lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125469s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s011s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125469s007s008lbl.pdf)
`
`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)
`
`Novo Nordisk Exhibit 2447
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Showing 1 to 15 of 15 entries
`
`Novo Nordisk Exhibit 2447
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`