`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 206073
`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=206073)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf#page=34)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf)
`
`Products on NDA 206073
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`GLYXAMBI
`
`GLYXAMBI
`
`EMPAGLIFLOZIN; LINAGLIPTIN
`
`EMPAGLIFLOZIN; LINAGLIPTIN
`
`10MG;5MG
`
`25MG;5MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`Yes
`
`Yes
`
`Showing 1 to 2 of 2 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 206073
`
`RS
`
`No
`
`Yes
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`01/30/2015
`
`ORIG-1
`
`Approval
`
`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/2015/206073s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`10/30/2023
`
`SUPPL-36
`
`10/13/2022
`
`SUPPL-33
`
`03/21/2022
`
`SUPPL-31
`
`Supplement
`Categories
`or Approval
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 206111Orig1s042; 208658Orig1s028;
`212614Orig1s020ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.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/2022/206073s031lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204629Orig1s034;206073Orig1s031;206111Orig1s031;208658Orig1s017ltr.pdf)
`
`06/11/2021
`
`SUPPL-30
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.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-27
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204629Orig1s028, 206073Orig1s027, 206111Orig1s025,
`208658Orig1s013, 212614Orig1s008ltr.pdf)
`
`Novo Nordisk Exhibit 2451
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`03/30/2020
`
`SUPPL-21
`
`01/24/2020
`
`SUPPL-23
`
`07/03/2019
`
`SUPPL-17
`
`07/01/2019
`
`SUPPL-22
`
`Supplement
`Categories
`or Approval
`Type
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201280Orig1s020, 201281Orig1s024, 206073Orig1s021,
`208026Orig1s012ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/206073Orig1s021.pdf)
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204629Orig1s023,206073Orig1s023,206111Orig1s022,208658Orig1s009ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017,
`208026Orig1s008ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/206073Orig1s017.pdf)
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022,
`208026Orig1s013ltr.pdf)
`
`10/26/2018
`
`SUPPL-19
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204629Orig1s018,206073Orig1s019,206111Orig1s018,208658Orig1s006ltr.pdf)
`
`12/13/2017
`
`SUPPL-12
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s012ltr.pdf)
`
`08/10/2017
`
`SUPPL-13
`
`08/10/2017
`
`SUPPL-11
`
`03/14/2017
`
`SUPPL-8
`
`12/23/2016
`
`SUPPL-9
`
`12/23/2016
`
`SUPPL-7
`
`07/08/2016
`
`SUPPL-6
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s013lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf)
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206073Orig1s011ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s007,s009ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206073Orig1s006ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`12/04/2015
`
`SUPPL-3
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206073Orig1s003ltr.pdf)
`
`08/28/2015
`
`SUPPL-1
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf)
`
`Showing 1 to 19 of 19 entries
`
`Labels for NDA 206073
`
`Label is
`not
`available
`on this
`site.
`
`
`
`Novo Nordisk Exhibit 2451
`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
`
`New Drug Application (NDA): 206073
`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=206073)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf#page=34)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206073Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 206073
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 206073
`
`Labels for NDA 206073
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`10/30/2023
`
`SUPPL-36
`
`10/13/2022
`
`SUPPL-33
`
`03/21/2022
`
`SUPPL-31
`
`Supplement
`Categories or
`Approval Type
`
`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/2023/206073s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s033lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206073s031lbl.pdf)
`
`06/11/2021
`
`SUPPL-30
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf)
`
`06/11/2021
`
`SUPPL-27
`
`03/30/2020
`
`SUPPL-21
`
`01/24/2020
`
`SUPPL-23
`
`01/24/2020
`
`SUPPL-23
`
`07/03/2019
`
`SUPPL-17
`
`07/01/2019
`
`SUPPL-22
`
`07/01/2019
`
`SUPPL-22
`
`10/26/2018
`
`SUPPL-19
`
`10/26/2018
`
`SUPPL-19
`
`12/13/2017
`
`SUPPL-12
`
`08/10/2017
`
`SUPPL-13
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206073s027s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206073s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206073s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206073s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s013lbl.pdf)
`
`Novo Nordisk Exhibit 2451
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`08/10/2017
`
`SUPPL-11
`
`03/14/2017
`
`SUPPL-8
`
`12/23/2016
`
`SUPPL-9
`
`12/23/2016
`
`SUPPL-7
`
`12/04/2015
`
`SUPPL-3
`
`08/28/2015
`
`SUPPL-1
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206073s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206073s7s9lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s001lbl.pdf)
`
`01/30/2015
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206073s000lbl.pdf)
`
`Showing 1 to 22 of 22 entries
`
`Novo Nordisk Exhibit 2451
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`