`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 201281
`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=201281)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf#page=21)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf)
`
`Products on NDA 201281
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`JENTADUETO
`
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE
`
`2.5MG;500MG
`
`TABLET;ORAL
`
`JENTADUETO
`
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE
`
`2.5MG;850MG
`
`TABLET;ORAL
`
`JENTADUETO
`
`LINAGLIPTIN; METFORMIN HYDROCHLORIDE
`
`2.5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`Yes
`
`Showing 1 to 3 of 3 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201281
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`01/30/2012
`
`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/2012/201281s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281_linagliptin_toc.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`06/20/2023
`
`SUPPL-35
`
`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/2023/201281s035lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201281Orig1s035;208026Orig1s024ltr.pdf)
`
`04/15/2022
`
`SUPPL-31
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201280Orig1s025; 201281Orig1s031ltr.pdf)
`
`03/30/2020
`
`SUPPL-24
`
`07/03/2019
`
`SUPPL-22
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.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/2019/201281s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s018, 201281Orig1s022, 206073Orig1s017,
`208026Orig1s008ltr.pdf)
`
`Novo Nordisk Exhibit 2423
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`07/01/2019
`
`SUPPL-25
`
`08/10/2017
`
`SUPPL-19
`
`03/14/2017
`
`SUPPL-17
`
`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/2019/201281s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022,
`208026Orig1s013ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s016,201281Orig1s019,208026Orig1s005,206073Orig1s013ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf)
`
`12/23/2016
`
`SUPPL-18
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf)
`
`12/23/2016
`
`SUPPL-14
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201281Orig1s014,s018ltr.pdf)
`
`04/29/2016
`
`SUPPL-12
`
`Manufacturing
`(CMC)
`
`02/11/2016
`
`SUPPL-11
`
`Manufacturing
`(CMC)
`
`09/18/2015
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`08/28/2015
`
`SUPPL-10
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s012,201281s010,206073Orig1s001ltr.pdf)
`
`07/28/2015
`
`SUPPL-8
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201280Orig1s011,201281Orig1s008ltr.pdf)
`
`07/30/2014
`
`SUPPL-6
`
`05/22/2014
`
`SUPPL-7
`
`E cacy-New
`Dosing Regimen
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201281Orig1s006ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201280Orig1s009,201281Orig1s007ltr.pdf)
`
`12/18/2013
`
`SUPPL-5
`
`Manufacturing
`(CMC)
`
`09/05/2013
`
`SUPPL-4
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s004ltr.pdf)
`
`06/18/2013
`
`SUPPL-3
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201281Orig1s003ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201281Orig1s002ltr.pdf)
`
`09/25/2012
`
`SUPPL-2
`
`Labeling-
`Container/Carton
`Labels
`
`Showing 1 to 20 of 20 entries
`
`Labels for NDA 201281
`
`Therapeutic Equivalents for NDA 201281
`
`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 2423
`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): 201281
`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=201281)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf#page=21)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 201281
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201281
`
`Labels for NDA 201281
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`06/20/2023
`
`SUPPL-35
`
`04/15/2022
`
`SUPPL-31
`
`03/30/2020
`
`SUPPL-24
`
`07/03/2019
`
`SUPPL-22
`
`07/01/2019
`
`SUPPL-25
`
`08/10/2017
`
`SUPPL-19
`
`03/14/2017
`
`SUPPL-17
`
`12/23/2016
`
`SUPPL-18
`
`12/23/2016
`
`SUPPL-14
`
`08/28/2015
`
`SUPPL-10
`
`07/28/2015
`
`SUPPL-8
`
`07/30/2014
`
`SUPPL-6
`
`05/22/2014
`
`SUPPL-7
`
`09/05/2013
`
`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
`
`E cacy-New Dosing
`Regimen
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201281s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201281s024lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201281s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201281s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201281S014S018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201281s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201281s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s004lbl.pdf)
`
`Novo Nordisk Exhibit 2423
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`06/18/2013
`
`SUPPL-3
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201281s003lbl.pdf)
`
`01/30/2012
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201281s000lbl.pdf)
`
`Showing 1 to 16 of 16 entries
`
`Therapeutic Equivalents for NDA 201281
`
`Note
`
`
`
`Novo Nordisk Exhibit 2423
`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): 201281
`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=201281)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035lbl.pdf#page=21)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201281Orig1s000SumR.pdf)
`
`Products on NDA 201281
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 201281
`
`Labels for NDA 201281
`
`Therapeutic Equivalents for NDA 201281
`
`
`
`
`
`
`
`
`
`JENTADUETO
`TABLET;ORAL; 2.5MG;500MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`JENTADUETO
`
`LINAGLIPTIN AND
`METFORMIN
`HYDROCHLORIDE
`
`Active
`Ingredients
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 2 of 2 entries
`
`TABLET;ORAL; 2.5MG;850MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`2.5MG;500MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`2.5MG;500MG
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`AB
`
`AB
`
`201281
`
`208336 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=208336)
`
`Company
`
`BOEHRINGER
`INGELHEIM
`
`SUNSHINE
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`Drug Name
`
`JENTADUETO
`
`LINAGLIPTIN AND
`METFORMIN
`HYDROCHLORIDE
`
`Active
`Ingredients
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`Showing 1 to 2 of 2 entries
`
`TABLET;ORAL; 2.5MG;1GM
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`JENTADUETO
`
`LINAGLIPTIN AND
`METFORMIN
`HYDROCHLORIDE
`
`Active
`Ingredients
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`LINAGLIPTIN;
`METFORMIN
`HYDROCHLORIDE
`
`Strength
`
`Dosage
`Form/Route
`
`2.5MG;850MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`2.5MG;850MG
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`AB
`
`AB
`
`201281
`
`208336 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=208336)
`
`BOEHRINGER
`INGELHEIM
`
`SUNSHINE
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`2.5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`2.5MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`AB
`
`AB
`
`201281
`
`208336 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=208336)
`
`Company
`
`BOEHRINGER
`INGELHEIM
`
`SUNSHINE
`
`Novo Nordisk Exhibit 2423
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Showing 1 to 2 of 2 entries
`
`Novo Nordisk Exhibit 2423
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`