`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
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`New Drug Application (NDA): 209091
`Company: ASTRAZENECA AB
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209091)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209091s008lbl.pdf#page=37)
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`Products on NDA 209091
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`CSV
`
`Excel
`
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`Drug Name
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`Active Ingredients
`
`Strength
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`Dosage Form/Route
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`Marketing Status
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`TE Code
`
`RLD
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`QTERN
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`QTERN
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`DAPAGLIFLOZIN; SAXAGLIPTIN
`HYDROCHLORIDE
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`DAPAGLIFLOZIN; SAXAGLIPTIN
`HYDROCHLORIDE
`
`Showing 1 to 2 of 2 entries
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`10MG;EQ 5MG BASE
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`TABLET;ORAL
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`Prescription
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`5MG;EQ 5MG BASE
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`TABLET;ORAL
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`Prescription
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`None
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`None
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`Yes
`
`Yes
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209091
`
`RS
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`Yes
`
`No
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`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
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`Excel
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`
`Action
`Date
`
`Submission
`
`02/27/2017
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`ORIG-1
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`Action
`Type
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`Approval
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`Submission
`Classi cation
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`Type 4 - New
`Combination
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`Review
`Priority;
`Orphan
`Status
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`STANDARD
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`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209091s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209091Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209091Orig1s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
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`Supplements
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`CSV
`
`Excel
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`
`Action
`Date
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`Submission
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`09/12/2023
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`SUPPL-8
`
`10/13/2022
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`SUPPL-7
`
`03/04/2022
`
`SUPPL-6
`
`01/24/2020
`
`SUPPL-5
`
`07/01/2019
`
`SUPPL-4
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`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert, Labeling-
`Patient Package
`Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209091s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209091Orig1s008ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209091Orig1s007ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209091Orig1s006ltr.pdf)
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209091s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s021, 205649Orig1s013, 209091Orig1s005,
`210874Orig1s003ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004,
`210874Orig1s001ltr.pdf)
`
`05/02/2019
`
`SUPPL-2
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209091Orig1s002ltr.pdf)
`
`Novo Nordisk Exhibit 2462
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf)
`
`Action
`Date
`
`Submission
`
`10/26/2018
`
`SUPPL-3
`
`Showing 1 to 7 of 7 entries
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`Labels for NDA 209091
`
`Note
`
`
`
`Novo Nordisk Exhibit 2462
`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): 209091
`Company: ASTRAZENECA AB
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209091)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209091s008lbl.pdf#page=37)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 209091
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209091
`
`Labels for NDA 209091
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/12/2023
`
`SUPPL-8
`
`09/12/2023
`
`SUPPL-8
`
`10/13/2022
`
`SUPPL-7
`
`03/04/2022
`
`SUPPL-6
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`01/24/2020
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`SUPPL-5
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`07/01/2019
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`SUPPL-4
`
`05/02/2019
`
`SUPPL-2
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`10/26/2018
`
`SUPPL-3
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Patient
`Package Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209091s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209091s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209091s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209091s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209091s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209091s003lbl.pdf)
`
`02/27/2017
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209091s000lbl.pdf)
`
`Showing 1 to 9 of 9 entries
`
`Novo Nordisk Exhibit 2462
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`