`
`Drugs@FDA: FDA-Approved Drugs
`
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`Biologic License Application (BLA): 125431
`Company: GLAXOSMITHKLINE LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=125431)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36)
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=316)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf)
`
`Products on BLA 125431
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`TANZEUM
`
`ALBIGLUTIDE
`
`30MG
`
`INJECTABLE;INJECTION
`
`Discontinued
`
`None
`
`RLD
`
`No
`
`RS
`
`No
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 125431
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`04/15/2014
`
`ORIG-1
`
`Approval
`
`Review
`Priority;
`Orphan
`Status
`
`N/A
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125431Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf)
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`12/20/2017
`
`SUPPL-20
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s020ltr.pdf)
`
`12/12/2017
`
`SUPPL-21
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s021ltr.pdf)
`
`08/01/2017
`
`SUPPL-19
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125431Orig1s019ltr.pdf)
`
`09/13/2016
`
`SUPPL-18
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125431Orig1s018ltr.pdf)
`
`07/27/2015
`
`SUPPL-14
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s014ltr.pdf)
`
`05/07/2015
`
`SUPPL-9
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s009ltr.pdf)
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2437
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`03/09/2015
`
`SUPPL-8
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125431Orig1s008ltr.pdf)
`
`Showing 1 to 7 of 7 entries
`
`Labels for BLA 125431
`
`Note
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2437
`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): 125431
`Company: GLAXOSMITHKLINE LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=125431)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf#page=36)
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=316)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125431Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on BLA 125431
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 125431
`
`Labels for BLA 125431
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`12/20/2017
`
`SUPPL-20
`
`12/20/2017
`
`SUPPL-20
`
`08/01/2017
`
`SUPPL-19
`
`08/01/2017
`
`SUPPL-19
`
`09/13/2016
`
`SUPPL-18
`
`05/07/2015
`
`SUPPL-9
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125431s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125431s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125431s009lbl.pdf)
`
`04/15/2014
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125431s000lbl.pdf)
`
`Showing 1 to 7 of 7 entries
`
`Novo Nordisk Exhibit 2437
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`