`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 206111
`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=206111)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf#page=44)
`
`Products on NDA 206111
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`SYNJARDY
`
`SYNJARDY
`
`SYNJARDY
`
`SYNJARDY
`
`EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`5MG;500MG
`
`TABLET;ORAL
`
`EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`5MG;1GM
`
`TABLET;ORAL
`
`EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`12.5MG;500MG
`
`TABLET;ORAL
`
`EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`12.5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`Yes
`
`Showing 1 to 4 of 4 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 206111
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`08/26/2015
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Type 4 - New
`Combination
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206111Orig1s000TOC.cfm)
`
`
`
`
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`10/30/2023
`
`SUPPL-42
`
`06/20/2023
`
`SUPPL-39
`
`06/20/2023
`
`SUPPL-38
`
`02/06/2023
`
`SUPPL-33
`
`10/13/2022
`
`SUPPL-36
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert
`
`Labeling-
`Package Insert
`
`E cacy-New
`Patient
`Population
`
`E cacy-New
`Indication
`
`Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028;
`212614Orig1s020ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s038,s039;208658Orig1s025,s026ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s033lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206111Orig1s033,208658Orig1s021ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s036lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s039,206073Orig1s033,206111Orig1s036,208658Orig1s023ltr.pdf)
`
`Novo Nordisk Exhibit 2453
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`03/21/2022
`
`SUPPL-31
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s031lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf)
`
`06/11/2021
`
`SUPPL-26
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.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-25
`
`01/24/2020
`
`SUPPL-22
`
`10/26/2018
`
`SUPPL-18
`
`Labeling-
`Package Insert
`
`Labeling-
`Medication
`Guide, Labeling-
`Package Insert
`
`Labeling-
`Medication
`Guide, Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025,
`208658Orig1s013, 212614Orig1s008ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.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/2018/206111s018lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf)
`
`12/13/2017
`
`SUPPL-15
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206111Orig1s015,208658Orig1s004ltr.pdf)
`
`12/23/2016
`
`SUPPL-4
`
`07/08/2016
`
`SUPPL-9
`
`07/08/2016
`
`SUPPL-6
`
`07/08/2016
`
`SUPPL-1
`
`05/06/2016
`
`SUPPL-8
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s004ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206111Orig1s001,s006,s009ltr.pdf)
`
`Labeling-
`Package Insert,
`Labeling-
`Medication Guide
`
`Labeling-
`Package Insert,
`Labeling-
`Medication Guide
`
`E cacy-New
`Indication
`
`Manufacturing
`(CMC)
`
`12/04/2015
`
`SUPPL-2
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206111Orig1s002ltr.pdf)
`
`Showing 1 to 17 of 17 entries
`
`Labels for NDA 206111
`
`Therapeutic Equivalents for NDA 206111
`
`Label is
`not
`available
`on this
`site.
`
`
`
`
`
`Novo Nordisk Exhibit 2453
`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): 206111
`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=206111)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf#page=44)
`
`Products on NDA 206111
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 206111
`
`Labels for NDA 206111
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`10/30/2023
`
`SUPPL-42
`
`06/20/2023
`
`SUPPL-39
`
`06/20/2023
`
`SUPPL-38
`
`02/06/2023
`
`SUPPL-33
`
`10/13/2022
`
`SUPPL-36
`
`03/21/2022
`
`SUPPL-31
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Patient Population
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s038s039,208658s025s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s033lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206111s031lbl.pdf)
`
`06/11/2021
`
`SUPPL-26
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf)
`
`06/11/2021
`
`SUPPL-25
`
`01/24/2020
`
`SUPPL-22
`
`01/24/2020
`
`SUPPL-22
`
`10/26/2018
`
`SUPPL-18
`
`10/26/2018
`
`SUPPL-18
`
`12/13/2017
`
`SUPPL-15
`
`12/23/2016
`
`SUPPL-4
`
`07/08/2016
`
`SUPPL-9
`
`07/08/2016
`
`SUPPL-9
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206111s025s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206111s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206111s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206111s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`
`Novo Nordisk Exhibit 2453
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`07/08/2016
`
`SUPPL-6
`
`07/08/2016
`
`SUPPL-6
`
`07/08/2016
`
`SUPPL-1
`
`12/04/2015
`
`SUPPL-2
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206111s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111s002lbl.pdf)
`
`08/26/2015
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206111lbl.pdf)
`
`Showing 1 to 21 of 21 entries
`
`Therapeutic Equivalents for NDA 206111
`
`Note
`
`
`
`Novo Nordisk Exhibit 2453
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 206111
`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=206111)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206111s042,208658s028lbl.pdf#page=44)
`
`Products on NDA 206111
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 206111
`
`Labels for NDA 206111
`
`Therapeutic Equivalents for NDA 206111
`
`SYNJARDY
`TABLET;ORAL; 5MG;500MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`5MG;500MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`206111
`
`BOEHRINGER
`INGELHEIM
`
`SYNJARDY
`
`EMPAGLIFLOZIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 5MG;1GM
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`SYNJARDY
`
`Yes
`
`AB
`
`206111
`
`5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`BOEHRINGER
`INGELHEIM
`
`EMPAGLIFLOZIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 12.5MG;500MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`12.5MG;500MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`206111
`
`BOEHRINGER
`INGELHEIM
`
`SYNJARDY
`
`EMPAGLIFLOZIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 12.5MG;1GM
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`SYNJARDY
`
`EMPAGLIFLOZIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 1 of 1 entries
`
`12.5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`206111
`
`BOEHRINGER
`INGELHEIM
`
`Novo Nordisk Exhibit 2453
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Novo Nordisk Exhibit 2453
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`