`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022341
`Company: NOVO NORDISK INC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022341)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf#page=31)
`
`Products on NDA 022341
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`VICTOZA
`
`LIRAGLUTIDE RECOMBINANT
`
`18MG/3ML (6MG/ML)
`
`SOLUTION;SUBCUTANEOUS
`
`Prescription
`
`None
`
`RLD
`
`Yes
`
`RS
`
`Yes
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022341
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`01/25/2010
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Type 1 - New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022341s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022341s000TOC.cfm)
`
`
`
`
`
`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
`
`07/05/2023
`
`SUPPL-39
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022341Orig1s039ltr.pdf)
`
`06/10/2022
`
`SUPPL-38
`
`Labeling-Package Insert,
`Labeling-Medication
`Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037, s038ltr.pdf)
`
`06/10/2022
`
`SUPPL-37
`
`Labeling-Package Insert
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022341Orig1s037, s038ltr.pdf)
`
`Label is not
`available on
`this site.
`
`11/20/2020
`
`SUPPL-36
`
`08/05/2020
`
`SUPPL-35
`
`Labeling-Package Insert,
`Labeling-Medication
`Guide
`
`Labeling-Package Insert,
`Labeling-Medication
`Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s036ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022341Orig1s035ltr.pdf)
`
`06/17/2019
`
`SUPPL-31
`
`E cacy-New Patient
`Population
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022341Orig1s031ltr.pdf)
`
`Novo Nordisk Exhibit 2408
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`08/25/2017
`
`SUPPL-27
`
`E cacy-New Indication
`
`07/26/2017
`
`SUPPL-29
`
`04/25/2017
`
`SUPPL-28
`
`REMS - MODIFIED - D-N-
`A
`
`Labeling-Medication
`Guide, Labeling-
`Container/Carton Labels
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s027ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/022341Orig1s027.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s029ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022341Orig1s028ltr.pdf)
`
`09/20/2016
`
`SUPPL-26
`
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s026ltr.pdf)
`
`04/22/2016
`
`SUPPL-25
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022341Orig1s025ltr.pdf)
`
`07/01/2015
`
`SUPPL-24
`
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s024ltr.pdf)
`
`03/09/2015
`
`SUPPL-23
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s023ltr.pdf)
`
`02/25/2015
`
`SUPPL-22
`
`Labeling-
`Container/Carton Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022341Orig1s022ltr.pdf)
`
`07/31/2014
`
`SUPPL-21
`
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022341Orig1s021ltr.pdf)
`
`06/13/2013
`
`SUPPL-20
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s020ltr.pdf)
`
`04/16/2013
`
`SUPPL-18
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022341Orig1s018ltr.pdf)
`
`12/13/2012
`
`SUPPL-17
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341Orig1s017ltr.pdf)
`
`12/03/2012
`
`SUPPL-10
`
`Manufacturing (CMC)
`
`04/06/2012
`
`SUPPL-13
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf)
`
`04/06/2012
`
`SUPPL-9
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf)
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022341s007,s009,s013ltr.pdf)
`
`Labeling-Package Insert,
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022341Orig1s004ltr.pdf)
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf)
`
`04/06/2012
`
`SUPPL-7
`
`05/18/2011
`
`SUPPL-4
`
`12/22/2010
`
`SUPPL-1
`
`Showing 1 to 24 of 24 entries
`
`Labels for NDA 022341
`
`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.
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2408
`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
`
`New Drug Application (NDA): 022341
`Company: NOVO NORDISK INC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022341)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf#page=31)
`
`Products on NDA 022341
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022341
`
`Labels for NDA 022341
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/05/2023
`
`SUPPL-39
`
`06/10/2022
`
`SUPPL-38
`
`06/10/2022
`
`SUPPL-38
`
`11/20/2020
`
`SUPPL-36
`
`11/20/2020
`
`SUPPL-36
`
`08/05/2020
`
`SUPPL-35
`
`08/05/2020
`
`SUPPL-35
`
`06/17/2019
`
`SUPPL-31
`
`08/25/2017
`
`SUPPL-27
`
`04/25/2017
`
`SUPPL-28
`
`04/25/2017
`
`SUPPL-28
`
`04/22/2016
`
`SUPPL-25
`
`03/09/2015
`
`SUPPL-23
`
`02/25/2015
`
`SUPPL-22
`
`06/13/2013
`
`SUPPL-20
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`E cacy-New Patient
`Population
`
`E cacy-New
`Indication
`
`Labeling-Medication
`Guide
`
`Labeling-
`Container/Carton
`Labels
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022341s039lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022341s037s038lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022341s035lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022341s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022341s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022341s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022341s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s020lbl.pdf)
`
`Novo Nordisk Exhibit 2408
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`04/16/2013
`
`SUPPL-18
`
`12/13/2012
`
`SUPPL-17
`
`04/06/2012
`
`SUPPL-13
`
`04/06/2012
`
`SUPPL-9
`
`04/06/2012
`
`SUPPL-7
`
`05/18/2011
`
`SUPPL-4
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022341s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022341s007s009s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf)
`
`05/18/2011
`
`SUPPL-4
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022341s004lbl.pdf)
`
`12/22/2010
`
`SUPPL-1
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341s001lbl.pdf)
`
`01/25/2010
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf)
`
`Showing 1 to 24 of 24 entries
`
`Novo Nordisk Exhibit 2408
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`