`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 209803
`Company: MSD SUB MERCK
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209803)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf#page=25)
`
`Products on NDA 209803
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`STEGLATRO
`
`STEGLATRO
`
`ERTUGLIFLOZIN
`
`ERTUGLIFLOZIN
`
`5MG
`
`15MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Showing 1 to 2 of 2 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209803
`
`RS
`
`No
`
`Yes
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`12/19/2017
`
`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/2017/209803s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209803Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209803,209805,209806Orig1s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`09/12/2023
`
`SUPPL-7
`
`10/13/2022
`
`SUPPL-6
`
`09/17/2021
`
`SUPPL-4
`
`01/24/2020
`
`SUPPL-2
`
`10/26/2018
`
`SUPPL-1
`
`Showing 1 to 5 of 5 entries
`
`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/2023/209803s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209803Orig1s007;209805Orig1s016;209806Orig1s010ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209803Orig1s006,209805Orig1s012,209806Orig1s009ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209803Orig1s004; 209805Orig1s008; 209806Orig1s006ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209803Orig1s002,209805Orig1s006,209806Orig1s002ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209803Orig1s001ltr.pdf)
`
`Novo Nordisk Exhibit 2465
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Labels for NDA 209803
`
`Therapeutic Equivalents for NDA 209803
`
`
`
`
`
`Novo Nordisk Exhibit 2465
`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): 209803
`Company: MSD SUB MERCK
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209803)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf#page=25)
`
`Products on NDA 209803
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209803
`
`Labels for NDA 209803
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/12/2023
`
`SUPPL-7
`
`10/13/2022
`
`SUPPL-6
`
`09/17/2021
`
`SUPPL-4
`
`01/24/2020
`
`SUPPL-2
`
`01/24/2020
`
`SUPPL-2
`
`10/26/2018
`
`SUPPL-1
`
`10/26/2018
`
`SUPPL-1
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209803s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209803s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209803s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209803s001lbl.pdf)
`
`12/19/2017
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209803s000lbl.pdf)
`
`Showing 1 to 8 of 8 entries
`
`Therapeutic Equivalents for NDA 209803
`
`
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2465
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 209803
`Company: MSD SUB MERCK
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209803)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209803s007lbl.pdf#page=25)
`
`Products on NDA 209803
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209803
`
`Labels for NDA 209803
`
`Therapeutic Equivalents for NDA 209803
`
`STEGLATRO
`TABLET;ORAL; 5MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`STEGLATRO
`
`ERTUGLIFLOZIN
`
`5MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`209803
`
`MSD SUB MERCK
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 15MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`STEGLATRO
`
`ERTUGLIFLOZIN
`
`15MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`209803
`
`MSD SUB MERCK
`
`Showing 1 to 1 of 1 entries
`
`Novo Nordisk Exhibit 2465
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`