`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 201280
`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=201280)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf#page=16)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf)
`
`Products on NDA 201280
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`TRADJENTA
`
`LINAGLIPTIN
`
`5MG
`
`TABLET;ORAL
`
`Prescription
`
`AB
`
`RLD
`
`Yes
`
`RS
`
`Yes
`
`Showing 1 to 1 of 1 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201280
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`05/02/2011
`
`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/2011/201280lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201280s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`06/20/2023
`
`SUPPL-27
`
`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/2023/201280s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201280Orig1s027ltr.pdf)
`
`04/15/2022
`
`SUPPL-25
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201280Orig1s025; 201281Orig1s031ltr.pdf)
`
`03/30/2020
`
`SUPPL-20
`
`07/03/2019
`
`SUPPL-18
`
`07/01/2019
`
`SUPPL-21
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201280s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201280Orig1s020, 201281Orig1s024, 206073Orig1s021,
`208026Orig1s012ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017,
`208026Orig1s008ltr.pdf)
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022,
`208026Orig1s013ltr.pdf)
`
`Novo Nordisk Exhibit 2415
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`08/10/2017
`
`SUPPL-16
`
`03/14/2017
`
`SUPPL-14
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert
`
`Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s016lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf)
`
`12/23/2016
`
`SUPPL-15
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201280Orig1s015,208026Orig1s004ltr.pdf)
`
`12/20/2016
`
`SUPPL-13
`
`Manufacturing
`(CMC)
`
`08/28/2015
`
`SUPPL-12
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf)
`
`07/28/2015
`
`SUPPL-11
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf)
`
`07/20/2015
`
`SUPPL-10
`
`Manufacturing
`(CMC)
`
`05/22/2014
`
`SUPPL-9
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf)
`
`06/18/2013
`
`SUPPL-6
`
`09/28/2012
`
`SUPPL-5
`
`08/13/2012
`
`SUPPL-4
`
`08/13/2012
`
`SUPPL-3
`
`05/22/2012
`
`SUPPL-2
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201280Orig1s006ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s005ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280Orig1s003,s004ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201280s002ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201280Orig1s002.pdf)
`
`Showing 1 to 18 of 18 entries
`
`Labels for NDA 201280
`
`Therapeutic Equivalents for NDA 201280
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`
`
`
`
`Novo Nordisk Exhibit 2415
`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): 201280
`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=201280)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf#page=16)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 201280
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201280
`
`Labels for NDA 201280
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`06/20/2023
`
`SUPPL-27
`
`04/15/2022
`
`SUPPL-25
`
`03/30/2020
`
`SUPPL-20
`
`07/03/2019
`
`SUPPL-18
`
`07/01/2019
`
`SUPPL-21
`
`08/10/2017
`
`SUPPL-16
`
`03/14/2017
`
`SUPPL-14
`
`12/23/2016
`
`SUPPL-15
`
`08/28/2015
`
`SUPPL-12
`
`07/28/2015
`
`SUPPL-11
`
`05/22/2014
`
`SUPPL-9
`
`06/18/2013
`
`SUPPL-6
`
`09/28/2012
`
`SUPPL-5
`
`08/13/2012
`
`SUPPL-4
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201280s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201280s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201280s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201280s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201280s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201280s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201280s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201280s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf)
`
`Novo Nordisk Exhibit 2415
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`08/13/2012
`
`SUPPL-3
`
`05/22/2012
`
`SUPPL-2
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s003s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201280s002lbl.pdf)
`
`05/02/2011
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201280lbl.pdf)
`
`Showing 1 to 17 of 17 entries
`
`Therapeutic Equivalents for NDA 201280
`
`Note
`
`
`
`Novo Nordisk Exhibit 2415
`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): 201280
`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=201280)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201280s027lbl.pdf#page=16)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201280Orig1s000SumR.pdf)
`
`Products on NDA 201280
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201280
`
`Labels for NDA 201280
`
`Therapeutic Equivalents for NDA 201280
`
`TRADJENTA
`TABLET;ORAL; 5MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`LINAGLIPTIN
`
`LINAGLIPTIN
`
`TRADJENTA
`
`LINAGLIPTIN
`
`5MG
`
`5MG
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`RLD
`
`No
`
`Yes
`
`TE
`Code
`
`AB
`
`AB
`
`Application No.
`
`208335 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=208335)
`
`201280
`
`Company
`
`SUNSHINE
`
`BOEHRINGER
`INGELHEIM
`
`Showing 1 to 2 of 2 entries
`
`Novo Nordisk Exhibit 2415
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`