`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 202293
`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=202293)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf#page=53)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf)
`
`Products on NDA 202293
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`FARXIGA
`
`FARXIGA
`
`DAPAGLIFLOZIN
`
`DAPAGLIFLOZIN
`
`Showing 1 to 2 of 2 entries
`
`5MG
`
`10MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202293
`
`RS
`
`No
`
`Yes
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`01/08/2014
`
`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/2014/202293s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`09/12/2023
`
`SUPPL-30
`
`05/08/2023
`
`SUPPL-26
`
`02/17/2023
`
`SUPPL-27
`
`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/2023/202293s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s030;205649Orig1s021ltr.pdf)
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert, Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s026ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/202293Orig1s026.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s027ltr.pdf)
`
`10/13/2022
`
`SUPPL-28
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202293Orig1s028,205649Orig1s018ltr.pdf)
`
`04/30/2021
`
`SUPPL-24
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202293Orig1s024ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s024TOC.cfm)
`
`Novo Nordisk Exhibit 2435
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`05/05/2020
`
`SUPPL-20
`
`02/03/2020
`
`SUPPL-22
`
`01/24/2020
`
`SUPPL-21
`
`10/18/2019
`
`SUPPL-18
`
`02/22/2019
`
`SUPPL-15
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-New
`Indication
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s020ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s020.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s022, 205649Orig1s014ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.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/2019/202293s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s018, 205649Orig1s011ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/202293Orig1s018.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s015, 205649Orig1s009ltr.pdf)
`
`10/26/2018
`
`SUPPL-17
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf)
`
`10/20/2017
`
`SUPPL-12
`
`03/01/2017
`
`SUPPL-11
`
`08/17/2016
`
`SUPPL-10
`
`06/14/2016
`
`SUPPL-9
`
`01/12/2016
`
`SUPPL-6
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s012ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf )
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202293Orig1s011ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s010ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202293Orig1s009ltr.pdf)
`
`Manufacturing
`(CMC)
`
`01/06/2016
`
`SUPPL-7
`
`Manufacturing
`(CMC)
`
`12/04/2015
`
`SUPPL-8
`
`03/11/2015
`
`SUPPL-2
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s008ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202293Orig1s002ltr.pdf)
`
`08/08/2014
`
`SUPPL-3
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202293Orig1s003ltr.pdf)
`
`07/31/2014
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`Showing 1 to 21 of 21 entries
`
`Labels for NDA 202293
`
`Therapeutic Equivalents for NDA 202293
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`
`
`
`
`Novo Nordisk Exhibit 2435
`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): 202293
`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=202293)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf#page=53)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 202293
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202293
`
`Labels for NDA 202293
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/12/2023
`
`SUPPL-30
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf)
`
`05/08/2023
`
`SUPPL-26
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s026lbl.pdf)
`
`02/17/2023
`
`SUPPL-27
`
`02/17/2023
`
`SUPPL-27
`
`10/13/2022
`
`SUPPL-28
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293Orig1s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202293s028lbl.pdf)
`
`04/30/2021
`
`SUPPL-24
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202293s024lbl.pdf)
`
`05/05/2020
`
`SUPPL-20
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s020lbl.pdf)
`
`02/03/2020
`
`SUPPL-22
`
`02/03/2020
`
`SUPPL-22
`
`01/24/2020
`
`SUPPL-21
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293Orig1s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202293s021lbl.pdf)
`
`10/18/2019
`
`SUPPL-18
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s018lbl.pdf)
`
`02/22/2019
`
`SUPPL-15
`
`10/26/2018
`
`SUPPL-17
`
`10/20/2017
`
`SUPPL-12
`
`03/01/2017
`
`SUPPL-11
`
`03/01/2017
`
`SUPPL-11
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202293s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202293s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf )
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202293s011lbl.pdf )
`
`Novo Nordisk Exhibit 2435
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`08/17/2016
`
`SUPPL-10
`
`08/17/2016
`
`SUPPL-10
`
`06/14/2016
`
`SUPPL-9
`
`12/04/2015
`
`SUPPL-8
`
`03/11/2015
`
`SUPPL-2
`
`08/08/2014
`
`SUPPL-3
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202293s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202293s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s003lbl.pdf)
`
`01/08/2014
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202293s000lbl.pdf)
`
`Showing 1 to 23 of 23 entries
`
`Therapeutic Equivalents for NDA 202293
`
`
`
`Novo Nordisk Exhibit 2435
`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): 202293
`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=202293)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202293s030lbl.pdf#page=53)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/202293Orig1s000SumR.pdf)
`
`Products on NDA 202293
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202293
`
`Labels for NDA 202293
`
`Therapeutic Equivalents for NDA 202293
`
`FARXIGA
`TABLET;ORAL; 5MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`FARXIGA
`
`DAPAGLIFLOZIN
`
`5MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`202293
`
`ASTRAZENECA AB
`
`Showing 1 to 1 of 1 entries
`
`TABLET;ORAL; 10MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`FARXIGA
`
`DAPAGLIFLOZIN
`
`10MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`202293
`
`ASTRAZENECA AB
`
`Showing 1 to 1 of 1 entries
`
`Novo Nordisk Exhibit 2435
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`