`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 205649
`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=205649)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf#page=59)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf)
`
`Products on NDA 205649
`
`CSV
`
`Excel
`
`
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`XIGDUO XR
`
`XIGDUO XR
`
`XIGDUO XR
`
`XIGDUO XR
`
`DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`5MG;500MG
`
`TABLET, EXTENDED RELEASE;ORAL
`
`DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`5MG;1GM
`
`TABLET, EXTENDED RELEASE;ORAL
`
`DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`10MG;500MG
`
`TABLET, EXTENDED RELEASE;ORAL
`
`DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`10MG;1GM
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`Yes
`
`No
`
`XIGDUO XR
`
`DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`2.5MG;1GM
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Showing 1 to 5 of 5 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 205649
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`10/29/2014
`
`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/2014/205649s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205649Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`09/12/2023
`
`SUPPL-21
`
`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/2023/205649s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202293Orig1s030;205649Orig1s021ltr.pdf)
`
`10/13/2022
`
`SUPPL-18
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202293Orig1s028,205649Orig1s018ltr.pdf)
`
`04/11/2022
`
`SUPPL-17
`
`02/03/2022
`
`SUPPL-16
`
`02/03/2020
`
`SUPPL-14
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205649Orig1s017ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/205649Orig1s016ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202293Orig1s022, 205649Orig1s014ltr.pdf)
`
`Novo Nordisk Exhibit 2449
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`01/24/2020
`
`SUPPL-13
`
`10/18/2019
`
`SUPPL-11
`
`08/12/2019
`
`SUPPL-12
`
`02/22/2019
`
`SUPPL-9
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Manufacturing
`(CMC)-Control
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s013lbl.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/2019/205649s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s018, 205649Orig1s011ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205649Orig1s012ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202293Orig1s015, 205649Orig1s009ltr.pdf)
`
`10/26/2018
`
`SUPPL-10
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205649s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202293Orig1s017,205649Origs010,209091Orig1s003ltr.pdf)
`
`07/28/2017
`
`SUPPL-8
`
`03/01/2017
`
`SUPPL-6
`
`01/10/2017
`
`SUPPL-7
`
`08/17/2016
`
`SUPPL-5
`
`06/14/2016
`
`SUPPL-4
`
`01/12/2016
`
`SUPPL-2
`
`Manufacturing
`(CMC)-New
`Strength
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`Manufacturing
`(CMC)
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf )
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205649Orig1s006ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s005ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205649Orig1s004ltr.pdf)
`
`Manufacturing
`(CMC)
`
`12/04/2015
`
`SUPPL-3
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205649Orig1s003ltr.pdf)
`
`09/01/2015
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`Showing 1 to 18 of 18 entries
`
`Labels for NDA 205649
`
`Note
`
`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 2449
`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): 205649
`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=205649)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf#page=59)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205649Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 205649
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 205649
`
`Labels for NDA 205649
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/12/2023
`
`SUPPL-21
`
`10/13/2022
`
`SUPPL-18
`
`04/11/2022
`
`SUPPL-17
`
`02/03/2022
`
`SUPPL-16
`
`02/03/2020
`
`SUPPL-14
`
`02/03/2020
`
`SUPPL-14
`
`01/24/2020
`
`SUPPL-13
`
`10/18/2019
`
`SUPPL-11
`
`02/22/2019
`
`SUPPL-9
`
`10/26/2018
`
`SUPPL-10
`
`07/28/2017
`
`SUPPL-8
`
`03/01/2017
`
`SUPPL-6
`
`03/01/2017
`
`SUPPL-6
`
`08/17/2016
`
`SUPPL-5
`
`08/17/2016
`
`SUPPL-5
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Manufacturing
`(CMC)-New Strength
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205649s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/205649s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205649s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205649s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205649s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s008lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf )
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205649s006lbl.pdf )
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205649s005lbl.pdf)
`
`Novo Nordisk Exhibit 2449
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`06/14/2016
`
`SUPPL-4
`
`12/04/2015
`
`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/2016/205649s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205649s003lbl.pdf)
`
`10/29/2014
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205649s000lbl.pdf)
`
`Showing 1 to 18 of 18 entries
`
`Novo Nordisk Exhibit 2449
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`