`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 204629
`Company: BOEHRINGER INGELHEIM
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204629)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf#page=47)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf)
`
`Products on NDA 204629
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`JARDIANCE
`
`JARDIANCE
`
`EMPAGLIFLOZIN
`
`EMPAGLIFLOZIN
`
`Showing 1 to 2 of 2 entries
`
`10MG
`
`25MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204629
`
`RS
`
`No
`
`Yes
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`08/01/2014
`
`ORIG-1
`
`Approval
`
`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/2014/204629s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204629Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`09/21/2023
`
`SUPPL-40
`
`Supplement
`Categories
`or Approval
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s040ltr.pdf)
`
`09/12/2023
`
`SUPPL-41
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s041lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s041ltr.pdf)
`
`06/20/2023
`
`SUPPL-42
`
`10/13/2022
`
`SUPPL-39
`
`03/21/2022
`
`SUPPL-34
`
`E cacy-New
`Patient
`Population
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204629Orig1s042ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf)
`
`Novo Nordisk Exhibit 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`02/24/2022
`
`SUPPL-33
`
`Supplement
`Categories
`or Approval
`Type
`
`E cacy-New
`Indication
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s033ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/204629Orig1s033.pdf)
`
`08/18/2021
`
`SUPPL-26
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s026ltr.pdf)
`
`06/11/2021
`
`SUPPL-29
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, s029; 206073Orig1s027, s030; 206111Orig1s025,
`s026; 208658Orig1s013, s015; 212614Orig1s008, s010ltr.pdf)
`
`06/11/2021
`
`SUPPL-28
`
`01/24/2020
`
`SUPPL-23
`
`12/21/2018
`
`SUPPL-19
`
`10/26/2018
`
`SUPPL-18
`
`12/13/2017
`
`SUPPL-16
`
`12/02/2016
`
`SUPPL-8
`
`07/08/2016
`
`SUPPL-12
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025,
`208658Orig1s013, 212614Orig1s008ltr.pdf)
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s019Ltr.pdf)
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204629Orig1s016ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s008ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s008.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s012ltr.pdf)
`
`Labeling-Patient
`Package Insert,
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Patient
`Package Insert,
`Labeling-Package
`Insert
`
`04/15/2016
`
`SUPPL-11
`
`Manufacturing
`(CMC)
`
`03/18/2016
`
`SUPPL-5
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s005ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s005.pdf)
`
`02/05/2016
`
`SUPPL-4
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204629Orig1s004ltr.pdf)
`
`01/21/2016
`
`SUPPL-10
`
`Manufacturing
`(CMC)
`
`01/12/2016
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`12/04/2015
`
`SUPPL-7
`
`06/26/2015
`
`SUPPL-3
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s007ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s007.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s003.pdf)
`
`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 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Action
`Date
`
`Submission
`
`06/26/2015
`
`SUPPL-2
`
`Supplement
`Categories
`or Approval
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s002.pdf)
`
`06/26/2015
`
`SUPPL-1
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204629Orig1s001,s002,s003ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/204629Orig1s001.pdf)
`
`Showing 1 to 24 of 24 entries
`
`Labels for NDA 204629
`
`Therapeutic Equivalents for NDA 204629
`
`
`
`
`
`Novo Nordisk Exhibit 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`
`
`
`
`
`
`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): 204629
`Company: BOEHRINGER INGELHEIM
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204629)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf#page=47)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf)
`
`Products on NDA 204629
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204629
`
`Labels for NDA 204629
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/21/2023
`
`SUPPL-40
`
`09/12/2023
`
`SUPPL-41
`
`06/20/2023
`
`SUPPL-42
`
`10/13/2022
`
`SUPPL-39
`
`03/21/2022
`
`SUPPL-34
`
`02/24/2022
`
`SUPPL-33
`
`08/18/2021
`
`SUPPL-26
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`E cacy-New Patient
`Population
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s041lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s042lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s039lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204629s033lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s026lbl.pdf)
`
`06/11/2021
`
`SUPPL-29
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf)
`
`06/11/2021
`
`SUPPL-28
`
`01/24/2020
`
`SUPPL-23
`
`01/24/2020
`
`SUPPL-23
`
`12/21/2018
`
`SUPPL-19
`
`10/26/2018
`
`SUPPL-18
`
`10/26/2018
`
`SUPPL-18
`
`12/13/2017
`
`SUPPL-16
`
`12/13/2017
`
`SUPPL-16
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Patient
`Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204629s028s029lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204629s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204629s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204629s016lbl.pdf)
`
`Novo Nordisk Exhibit 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Action Date
`
`Submission
`
`12/02/2016
`
`SUPPL-8
`
`03/18/2016
`
`SUPPL-5
`
`02/05/2016
`
`SUPPL-4
`
`12/04/2015
`
`SUPPL-7
`
`06/26/2015
`
`SUPPL-3
`
`06/26/2015
`
`SUPPL-2
`
`06/26/2015
`
`SUPPL-1
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204629s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204629s001s002s003lbl.pdf)
`
`08/01/2014
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204629s000lbl.pdf)
`
`Showing 1 to 24 of 24 entries
`
`Therapeutic Equivalents for NDA 204629
`
`
`
`Novo Nordisk Exhibit 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 204629
`Company: BOEHRINGER INGELHEIM
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204629)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204629s040lbl.pdf#page=47)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204629Orig1s000SumR.pdf)
`
`Products on NDA 204629
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204629
`
`Labels for NDA 204629
`
`Therapeutic Equivalents for NDA 204629
`
`JARDIANCE
`TABLET;ORAL; 10MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`JARDIANCE
`
`EMPAGLIFLOZIN
`
`10MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`204629
`
`BOEHRINGER
`INGELHEIM
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 25MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`JARDIANCE
`
`EMPAGLIFLOZIN
`
`25MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`204629
`
`BOEHRINGER
`INGELHEIM
`
`Showing 1 to 1 of 1 entries
`
`Novo Nordisk Exhibit 2440
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`