`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022350
`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=022350)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf)
`
`Products on NDA 022350
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`ONGLYZA
`
`ONGLYZA
`
`SAXAGLIPTIN HYDROCHLORIDE
`
`EQ 2.5MG BASE
`
`TABLET;ORAL
`
`SAXAGLIPTIN HYDROCHLORIDE
`
`EQ 5MG BASE
`
`TABLET;ORAL
`
`Discontinued
`
`Discontinued
`
`None
`
`None
`
`Yes
`
`Yes
`
`Showing 1 to 2 of 2 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022350
`
`RS
`
`No
`
`No
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/31/2009
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`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/2009/022350lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/01/2019
`
`SUPPL-23
`
`02/27/2017
`
`SUPPL-18
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022350Orig1s023, 200678Orig1s024, 209091Orig1s004,
`210874Orig1s001ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf)
`
`01/18/2017
`
`SUPPL-19
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s019ltr.pdf)
`
`04/05/2016
`
`SUPPL-14
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`11/25/2015
`
`SUPPL-17
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf)
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2404
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`08/28/2015
`
`SUPPL-16
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf)
`
`01/23/2014
`
`SUPPL-13
`
`Manufacturing (CMC)
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022350Orig1s011ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022350s009ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s004ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s007ltr.pdf)
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022350s001,s002ltr.pdf)
`
`05/24/2013
`
`SUPPL-11
`
`03/13/2012
`
`SUPPL-9
`
`12/16/2011
`
`SUPPL-4
`
`11/15/2011
`
`SUPPL-7
`
`02/18/2011
`
`SUPPL-2
`
`02/18/2011
`
`SUPPL-1
`
`Showing 1 to 13 of 13 entries
`
`Labels for NDA 022350
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2404
`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): 022350
`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=022350)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf#page=31)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022350s000_SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 022350
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022350
`
`Labels for NDA 022350
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/01/2019
`
`SUPPL-23
`
`02/27/2017
`
`SUPPL-18
`
`01/18/2017
`
`SUPPL-19
`
`04/05/2016
`
`SUPPL-14
`
`08/28/2015
`
`SUPPL-16
`
`05/24/2013
`
`SUPPL-11
`
`12/16/2011
`
`SUPPL-4
`
`11/15/2011
`
`SUPPL-7
`
`02/18/2011
`
`SUPPL-2
`
`02/18/2011
`
`SUPPL-1
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`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
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022350s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022350s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022350s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022350s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022350s001s002lbl.pdf)
`
`07/31/2009
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022350lbl.pdf)
`
`Showing 1 to 11 of 11 entries
`
`Novo Nordisk Exhibit 2404
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`