`
`Drugs@FDA: FDA-Approved Drugs
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`New Drug Application (NDA): 200678
`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=200678)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf#page=47)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf)
`
`Products on NDA 200678
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`KOMBIGLYZE XR
`
`KOMBIGLYZE XR
`
`KOMBIGLYZE XR
`
`METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
`HYDROCHLORIDE
`
`METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
`HYDROCHLORIDE
`
`METFORMIN HYDROCHLORIDE; SAXAGLIPTIN
`HYDROCHLORIDE
`
`Showing 1 to 3 of 3 entries
`
`500MG;EQ 5MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Discontinued
`
`1GM;EQ 5MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Discontinued
`
`1GM;EQ 2.5MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Discontinued
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 200678
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`11/05/2010
`
`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/2010/200678s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200678s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678_kombiglyze_xr_toc.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/01/2019
`
`SUPPL-24
`
`02/27/2017
`
`SUPPL-18
`
`01/18/2017
`
`SUPPL-20
`
`01/18/2017
`
`SUPPL-19
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.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/2017/200678s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022350Orig1s018,200678Orig1s018ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200678Orig1s019,s020ltr.pdf)
`
`Novo Nordisk Exhibit 2412
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`04/05/2016
`
`SUPPL-13
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf)
`
`08/28/2015
`
`SUPPL-16
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022350Orig1s016,200678Orig1s016ltr.pdf)
`
`02/09/2015
`
`SUPPL-14
`
`Manufacturing (CMC)
`
`05/24/2013
`
`SUPPL-10
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`05/15/2013
`
`SUPPL-2
`
`Manufacturing (CMC)
`
`11/08/2012
`
`SUPPL-9
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200678Orig1s010ltr.pdf)
`
`Labeling-
`Container/Carton
`Labels
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s007ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf)
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200678s003,s004ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200678s005ltr.pdf)
`
`04/01/2012
`
`SUPPL-7
`
`03/07/2012
`
`SUPPL-4
`
`03/07/2012
`
`SUPPL-3
`
`11/15/2011
`
`SUPPL-5
`
`Showing 1 to 14 of 14 entries
`
`Labels for NDA 200678
`
`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 2412
`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): 200678
`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=200678)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf#page=47)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200678Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 200678
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 200678
`
`Labels for NDA 200678
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/01/2019
`
`SUPPL-24
`
`02/27/2017
`
`SUPPL-18
`
`01/18/2017
`
`SUPPL-20
`
`01/18/2017
`
`SUPPL-19
`
`04/05/2016
`
`SUPPL-13
`
`08/28/2015
`
`SUPPL-16
`
`05/24/2013
`
`SUPPL-10
`
`03/07/2012
`
`SUPPL-4
`
`03/07/2012
`
`SUPPL-3
`
`11/15/2011
`
`SUPPL-5
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`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
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200678s024lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/200678s019s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200678s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200678s016lbledt.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200678s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200678s003s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200678s005lbl.pdf)
`
`11/05/2010
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200678s000lbl.pdf)
`
`Showing 1 to 11 of 11 entries
`
`Novo Nordisk Exhibit 2412
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`