`
`Drugs@FDA: FDA-Approved Drugs
`
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`New Drug Application (NDA): 208026
`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=208026)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208026s024lbl.pdf#page=22)
`Summary Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000SumR.pdf)
`
`Products on NDA 208026
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`CSV
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`Excel
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`Drug Name
`
`Active Ingredients
`
`Strength
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`Dosage Form/Route
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`Marketing Status
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`TE Code
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`RLD
`
`JENTADUETO XR
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`LINAGLIPTIN; METFORMIN HYDROCHLORIDE
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`2.5MG;1GM
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`TABLET, EXTENDED RELEASE;ORAL
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`JENTADUETO XR
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`LINAGLIPTIN; METFORMIN HYDROCHLORIDE
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`5MG;1GM
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`TABLET, EXTENDED RELEASE;ORAL
`
`Prescription
`
`Prescription
`
`None
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`None
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`Yes
`
`Yes
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`Showing 1 to 2 of 2 entries
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 208026
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`RS
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`No
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`Yes
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`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
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`
`Action
`Date
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`Submission
`
`Action
`Type
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`Submission
`Classi cation
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`05/27/2016
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`ORIG-1
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`Approval
`
`Type 4 - New
`Combination
`
`Review
`Priority;
`Orphan
`Status
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`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208026Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
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`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`06/20/2023
`
`SUPPL-24
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`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/2023/201281s035,208026s024lbl.pdf#page=24)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201281Orig1s035;208026Orig1s024ltr.pdf)
`
`10/01/2021
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`SUPPL-20
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208026s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208026Orig1s020ltr.pdf)
`
`03/30/2020
`
`SUPPL-12
`
`07/03/2019
`
`SUPPL-8
`
`07/01/2019
`
`SUPPL-13
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208026s012lbl.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/2019/208026s008lbl.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/2019/208026s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201280Orig1s021, 201281Orig1s025, 206073Orig1s022,
`208026Orig1s013ltr.pdf)
`
`Novo Nordisk Exhibit 2424
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`08/10/2017
`
`SUPPL-5
`
`03/14/2017
`
`SUPPL-3
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Package Insert
`
`Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s005lbl.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/2017/208026s003lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201280Orig1s014,201281Orig1s017,206073Orig1s008,208026Orig1s003ltr.pdf)
`
`12/23/2016
`
`SUPPL-4
`
`Labeling-
`Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201280Orig1s015,208026Orig1s004ltr.pdf)
`
`Showing 1 to 8 of 8 entries
`
`Labels for NDA 208026
`
`
`
`Novo Nordisk Exhibit 2424
`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): 208026
`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=208026)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208026s024lbl.pdf#page=22)
`Summary Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208026Orig1s000SumR.pdf)
`
`Products on NDA 208026
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 208026
`
`Labels for NDA 208026
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`06/20/2023
`
`SUPPL-24
`
`10/01/2021
`
`SUPPL-20
`
`03/30/2020
`
`SUPPL-12
`
`07/03/2019
`
`SUPPL-8
`
`07/01/2019
`
`SUPPL-13
`
`08/10/2017
`
`SUPPL-5
`
`03/14/2017
`
`SUPPL-3
`
`12/23/2016
`
`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
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201281s035,208026s024lbl.pdf#page=24)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208026s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208026s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208026s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208026s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208026s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s004lbl.pdf)
`
`05/27/2016
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208026s000lbl.pdf)
`
`Showing 1 to 9 of 9 entries
`
`
`
`
`
`
`
`Note
`
`Novo Nordisk Exhibit 2424
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`