`
`Drugs@FDA: FDA-Approved Drugs
`
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`
`Biologic License Application (BLA): 208583
`Company: NOVO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=208583)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf#page=42)
`This Former NDA Was Deemed To Be a BLA on March 23, 2020. (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla)
`
`Products on BLA 208583
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`+
`
`XULTOPHY 100/3.6
`
`INSULIN DEGLUDEC;
`LIRAGLUTIDE
`
`300 UNITS/3ML;10.8MG/3ML (100
`UNITS/ML;3.6MG/ML)
`
`SOLUTION;SUBCUTANEOUS
`
`Prescription
`
`None
`
`RLD
`
`No
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 208583
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`11/21/2016
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Review
`Priority;
`Orphan
`Status
`
`N/A
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208583Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla)
`
`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
`
`07/10/2023
`
`SUPPL-21
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208583Orig1s021ltr.pdf)
`
`06/10/2022
`
`SUPPL-19
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf)
`
`06/10/2022
`
`SUPPL-18
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208583Orig1s018, s019ltr.pdf)
`
`11/15/2019
`
`SUPPL-15
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf)
`
`11/15/2019
`
`SUPPL-14
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s014, s015ltr.pdf)
`
`08/08/2019
`
`SUPPL-12
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s012ltr.pdf)
`
`02/27/2019
`
`SUPPL-11
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf)
`
`Novo Nordisk Exhibit 2460
`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
`
`02/27/2019
`
`SUPPL-10
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf)
`
`02/27/2019
`
`SUPPL-8
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s008s010s011ltr.pdf)
`
`02/01/2019
`
`SUPPL-3
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf)
`
`02/01/2019
`
`SUPPL-2
`
`Supplement
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208583Orig1s002, s003ltr.pdf)
`
`12/12/2017
`
`SUPPL-1
`
`Supplement
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208583Orig1s001ltr.pdf)
`
`Showing 1 to 12 of 12 entries
`
`Labels for BLA 208583
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2460
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`
`
`
`
`
`
`Note
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`Biologic License Application (BLA): 208583
`Company: NOVO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=208583)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf#page=42)
`This Former NDA Was Deemed To Be a BLA on March 23, 2020. (https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=faq.page#nda_bla)
`
`Products on BLA 208583
`
`Approval Date(s) and History, Letters, Labels, Reviews for BLA 208583
`
`Labels for BLA 208583
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/10/2023
`
`SUPPL-21
`
`06/10/2022
`
`SUPPL-19
`
`06/10/2022
`
`SUPPL-19
`
`06/10/2022
`
`SUPPL-18
`
`06/10/2022
`
`SUPPL-18
`
`06/10/2022
`
`SUPPL-18
`
`11/15/2019
`
`SUPPL-15
`
`11/15/2019
`
`SUPPL-15
`
`11/15/2019
`
`SUPPL-14
`
`11/15/2019
`
`SUPPL-14
`
`08/08/2019
`
`SUPPL-12
`
`02/27/2019
`
`SUPPL-11
`
`02/27/2019
`
`SUPPL-10
`
`02/01/2019
`
`SUPPL-3
`
`02/01/2019
`
`SUPPL-2
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208583s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208583s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s014s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s008s010s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208583s002s003lbl.pdf)
`
`Novo Nordisk Exhibit 2460
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`11/21/2016
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208583s000lbl.pdf)
`
`Showing 1 to 16 of 16 entries
`
`Novo Nordisk Exhibit 2460
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`