`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021773
`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=021773)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf#page=33)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm)
`
`Products on NDA 021773
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`BYETTA
`
`BYETTA
`
`EXENATIDE SYNTHETIC
`
`300MCG/1.2ML (250MCG/ML)
`
`INJECTABLE;SUBCUTANEOUS
`
`EXENATIDE SYNTHETIC
`
`600MCG/2.4ML (250MCG/ML)
`
`INJECTABLE;SUBCUTANEOUS
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`Yes
`
`Yes
`
`RS
`
`Yes
`
`Yes
`
`
`
`
`
`Showing 1 to 2 of 2 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021773
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`04/28/2005
`
`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/2005/021773lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021773ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021773_ByettaTOC.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`12/21/2022
`
`SUPPL-48
`
`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/2022/021773s048lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s048ltr.pdf)
`
`06/10/2022
`
`SUPPL-47
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046, s047ltr.pdf)
`
`06/10/2022
`
`SUPPL-46
`
`11/04/2021
`
`SUPPL-45
`
`Labeling-
`Container/Carton
`Labels
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021773Orig1s046, s047ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s045lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s045ltr.pdf)
`
`06/17/2021
`
`SUPPL-44
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021773Orig1s044ltr.pdf)
`
`02/28/2020
`
`SUPPL-43
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021773Orig1s043ltr.pdf)
`
`Novo Nordisk Exhibit 2396
`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/2018/021773s041lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021773Orig1s040ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021773Orig1s036ltr.pdf)
`
`Action
`Date
`
`Submission
`
`12/20/2018
`
`SUPPL-41
`
`02/25/2015
`
`SUPPL-40
`
`11/24/2014
`
`SUPPL-36
`
`08/12/2014
`
`SUPPL-39
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Package Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Manufacturing
`(CMC)
`
`06/04/2014
`
`SUPPL-38
`
`Manufacturing
`(CMC)
`
`06/04/2014
`
`SUPPL-37
`
`Manufacturing
`(CMC)
`
`04/23/2014
`
`SUPPL-35
`
`Manufacturing
`(CMC)
`
`01/30/2014
`
`SUPPL-34
`
`Manufacturing
`(CMC)
`
`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.
`
`10/19/2011
`
`SUPPL-30
`
`10/19/2011
`
`SUPPL-29
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf )
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s029,s030ltr.pdf)
`
`08/05/2011
`
`SUPPL-31
`
`REMS-Assessment
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021773s031ltr.pdf)
`
`11/12/2010
`
`SUPPL-28
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s028ltr.pdf)
`
`08/13/2010
`
`SUPPL-26
`
`Labeling-
`Container/Carton
`Labels
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021773s026ltr.pdf)
`
`10/30/2009
`
`SUPPL-25
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`10/30/2009
`
`SUPPL-22
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`10/30/2009
`
`SUPPL-18
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`10/30/2009
`
`SUPPL-17
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`Novo Nordisk Exhibit 2396
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`10/30/2009
`
`SUPPL-11
`
`Labeling
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`10/30/2009
`
`SUPPL-9
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021773s009s011s017s018s022s025021919ltr.pdf)
`
`06/17/2008
`
`SUPPL-10
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s010ltr.pdf)
`
`01/11/2008
`
`SUPPL-12
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021773s012ltr.pdf)
`
`02/10/2007
`
`SUPPL-7
`
`Labeling-Package
`Insert, Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021773s007ltr.pdf)
`
`12/22/2006
`
`SUPPL-6
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf)
`
`12/22/2006
`
`SUPPL-2
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s002, s006ltr.pdf)
`
`11/01/2006
`
`SUPPL-5
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s005ltr.pdf)
`
`10/12/2006
`
`SUPPL-4
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021773s004LTR.pdf)
`
`Showing 1 to 32 of 32 entries
`
`Labels for NDA 021773
`
`
`
`Novo Nordisk Exhibit 2396
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`
`
`
`
`
`
`Note
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021773
`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=021773)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773s048lbl.pdf#page=33)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm113705.htm)
`
`Products on NDA 021773
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021773
`
`Labels for NDA 021773
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`12/21/2022
`
`SUPPL-48
`
`06/10/2022
`
`SUPPL-47
`
`06/10/2022
`
`SUPPL-46
`
`11/04/2021
`
`SUPPL-45
`
`06/17/2021
`
`SUPPL-44
`
`02/28/2020
`
`SUPPL-43
`
`12/20/2018
`
`SUPPL-41
`
`02/25/2015
`
`SUPPL-40
`
`02/25/2015
`
`SUPPL-40
`
`11/24/2014
`
`SUPPL-36
`
`10/19/2011
`
`SUPPL-30
`
`10/19/2011
`
`SUPPL-29
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`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/2022/021773s048lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021773Orig1s046s047lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s045lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021773s044lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021773s043lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021773s041lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021773s040lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021773s036lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021773s029s030lbl.pdf)
`
`11/12/2010
`
`SUPPL-28
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021773s028lbl.pdf)
`
`10/30/2009
`
`SUPPL-25
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`10/30/2009
`
`SUPPL-22
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`Novo Nordisk Exhibit 2396
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Action Date
`
`Submission
`
`10/30/2009
`
`SUPPL-18
`
`10/30/2009
`
`SUPPL-17
`
`10/30/2009
`
`SUPPL-11
`
`10/30/2009
`
`SUPPL-9
`
`06/17/2008
`
`SUPPL-10
`
`01/11/2008
`
`SUPPL-12
`
`02/10/2007
`
`SUPPL-7
`
`02/10/2007
`
`SUPPL-7
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021773s9s11s18s22s25lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021773s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021773s007lbl.pdf)
`
`12/22/2006
`
`SUPPL-6
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf)
`
`12/22/2006
`
`SUPPL-2
`
`11/01/2006
`
`SUPPL-5
`
`10/12/2006
`
`SUPPL-4
`
`04/28/2005
`
`ORIG-1
`
`Showing 1 to 28 of 28 entries
`
`E cacy-New
`Indication
`
`Labeling
`
`Labeling
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s022s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021773s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021773lbl.pdf)
`
`Novo Nordisk Exhibit 2396
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`