`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022200
`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=022200)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf)
`
`Products on NDA 022200
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`BYDUREON
`
`EXENATIDE SYNTHETIC
`
`2MG/VIAL
`
`FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
`
`BYDUREON PEN
`
`EXENATIDE SYNTHETIC
`
`2MG
`
`FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
`
`Discontinued
`
`Discontinued
`
`None
`
`None
`
`Yes
`
`Yes
`
`No
`
`No
`
`Showing 1 to 2 of 2 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022200
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`01/27/2012
`
`ORIG-1
`
`Approval
`
`Type 3 - New
`Dosage Form
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022200Orig1s000_corrected_ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf)
`
`Notes
`
`test
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`12/21/2022
`
`SUPPL-34
`
`07/26/2022
`
`SUPPL-32
`
`06/10/2022
`
`SUPPL-33
`
`07/22/2021
`
`SUPPL-31
`
`02/28/2020
`
`SUPPL-30
`
`02/15/2019
`
`SUPPL-28
`
`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/2022/022200s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s034ltr.pdf)
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s032ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s033lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022200Orig1s033ltr.pdf)
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022200s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022200Orig1s031ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022200Orig1s030ltr.pdf)
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022200s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022200Orig1s028ltr.pdf)
`
`Novo Nordisk Exhibit 2418
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022200s026ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022200Orig1s025ltr.pdf)
`
`Action
`Date
`
`Submission
`
`04/02/2018
`
`SUPPL-26
`
`10/20/2017
`
`SUPPL-25
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`06/10/2016
`
`SUPPL-24
`
`Manufacturing (CMC)
`
`01/11/2016
`
`SUPPL-23
`
`Manufacturing (CMC)
`
`12/31/2015
`
`SUPPL-21
`
`Manufacturing (CMC)
`
`12/23/2015
`
`SUPPL-22
`
`Manufacturing (CMC)
`
`09/24/2015
`
`SUPPL-18
`
`09/24/2015
`
`SUPPL-17
`
`09/24/2015
`
`SUPPL-16
`
`09/24/2015
`
`SUPPL-15
`
`09/18/2015
`
`SUPPL-20
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s015,s016,s017,s018ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s020ltr.pdf)
`
`08/14/2015
`
`SUPPL-11
`
`Manufacturing (CMC)
`
`04/29/2015
`
`SUPPL-10
`
`REMS-Assessment,
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s010ltr.pdf)
`
`03/09/2015
`
`SUPPL-19
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s019ltr.pdf)
`
`03/05/2015
`
`SUPPL-14
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022200Orig1s014ltr.pdf)
`
`05/22/2014
`
`SUPPL-13
`
`05/22/2014
`
`SUPPL-12
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s012,s013ltr.pdf)
`
`03/24/2014
`
`SUPPL-9
`
`Manufacturing (CMC)
`
`02/28/2014
`
`SUPPL-8
`
`02/28/2014
`
`SUPPL-7
`
`Labeling-Package
`Insert
`
`Labeling-Proprietary
`Name Change
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022200Orig1s008ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022200Orig1s008.pdf)
`
`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.
`
`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 2418
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`06/12/2013
`
`SUPPL-4
`
`Manufacturing (CMC)
`
`02/27/2013
`
`SUPPL-5
`
`Manufacturing (CMC)
`
`Showing 1 to 28 of 28 entries
`
`Labels for NDA 022200
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2418
`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): 022200
`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=022200)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf#page=37)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022200Orig1s000SumRedt.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 022200
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022200
`
`Labels for NDA 022200
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`12/21/2022
`
`SUPPL-34
`
`07/26/2022
`
`SUPPL-32
`
`06/10/2022
`
`SUPPL-33
`
`07/22/2021
`
`SUPPL-31
`
`02/28/2020
`
`SUPPL-30
`
`02/15/2019
`
`SUPPL-28
`
`04/02/2018
`
`SUPPL-26
`
`10/20/2017
`
`SUPPL-25
`
`09/24/2015
`
`SUPPL-18
`
`09/24/2015
`
`SUPPL-17
`
`09/24/2015
`
`SUPPL-16
`
`09/24/2015
`
`SUPPL-15
`
`09/18/2015
`
`SUPPL-20
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-
`Container/Carton
`Labels
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s032lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022200s033lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022200s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022200s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022200s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022200s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022200s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s015s016s017s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s020lbl.pdf)
`
`Novo Nordisk Exhibit 2418
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Action Date
`
`Submission
`
`03/09/2015
`
`SUPPL-19
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s019lbl.pdf)
`
`03/05/2015
`
`SUPPL-14
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022200s014lbl.pdf)
`
`Note
`
`This
`supplement
`type does not
`usually require
`new labeling.
`
`05/22/2014
`
`SUPPL-13
`
`05/22/2014
`
`SUPPL-12
`
`02/28/2014
`
`SUPPL-8
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s012s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022200s008lbl.pdf)
`
`01/27/2012
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200Orig1s000lbledt.pdf)
`
`test
`
`Showing 1 to 19 of 19 entries
`
`Novo Nordisk Exhibit 2418
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`