`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 209637
`Company: NOVO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209637)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf#page=27)
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`Products on NDA 209637
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`CSV
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`Excel
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`Drug Name
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`Active Ingredients
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`Strength
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`Dosage Form/Route
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`Marketing Status
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`TE Code
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`RLD
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`RS
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`OZEMPIC
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`OZEMPIC
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`OZEMPIC
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`OZEMPIC
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`SEMAGLUTIDE
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`SEMAGLUTIDE
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`SEMAGLUTIDE
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`SEMAGLUTIDE
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`Showing 1 to 4 of 4 entries
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`2MG/1.5ML (1.34MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`4MG/3ML (1.34MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`8MG/3ML (2.68MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`2MG/3ML (0.68MG/ML)
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`SOLUTION;SUBCUTANEOUS
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`Prescription
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`Prescription
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`Prescription
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`Prescription
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`None
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`None
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`None
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`None
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`Yes
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`Yes
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`Yes
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`Yes
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`Yes
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`Yes
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`Yes
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`Yes
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209637
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`Original Approvals or Tentative Approvals
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`CSV
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`Excel
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`Action
`Date
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`Submission
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`12/05/2017
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`ORIG-1
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`Action
`Type
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`Approval
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`Submission
`Classi cation
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`Type 1 - New
`Molecular Entity
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`Review
`Priority;
`Orphan
`Status
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`STANDARD
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`Letters, Reviews, Labels, Patient Package Insert
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`Notes
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209637s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm)
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`
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`Showing 1 to 1 of 1 entries
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`Supplements
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`CSV
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`Excel
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`Action Date
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`Submission
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`Supplement
`Categories or
`Approval Type
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`Letters, Reviews, Labels, Patient Package Insert
`
`Note
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`09/22/2023
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`SUPPL-21
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`Labeling-Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf)
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`09/22/2023
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`SUPPL-20
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`Labeling-Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209637Orig1s020,s021ltr.pdf)
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`10/06/2022
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`SUPPL-12
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`Labeling-
`Container/Carton
`Labels, Labeling-
`Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s012ltr.pdf)
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`03/28/2022
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`SUPPL-9
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`E cacy-New Dosing
`Regimen
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637Orig1s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209637Orig1s009ltr.pdf)
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`04/12/2021
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`SUPPL-8
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`Labeling-Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209637Orig1s008ltr.pdf)
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`01/16/2020
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`SUPPL-3
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`E cacy-New Indication
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209637Orig1s003ltr.pdf)
`
`Novo Nordisk Exhibit 2463
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action Date
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`Submission
`
`11/27/2019
`
`SUPPL-4
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`Supplement
`Categories or
`Approval Type
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s004ltr.pdf)
`
`04/09/2019
`
`SUPPL-1
`
`Labeling-
`Container/Carton Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209637Orig1s001ltr.pdf)
`
`Showing 1 to 8 of 8 entries
`
`Labels for NDA 209637
`
`
`
`Novo Nordisk Exhibit 2463
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
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`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 209637
`Company: NOVO
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=209637)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf#page=27)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 209637
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 209637
`
`Labels for NDA 209637
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`09/22/2023
`
`SUPPL-21
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`09/22/2023
`
`SUPPL-20
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`10/06/2022
`
`SUPPL-12
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`10/06/2022
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`SUPPL-12
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`03/28/2022
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`SUPPL-9
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`04/12/2021
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`SUPPL-8
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`01/16/2020
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`11/27/2019
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`SUPPL-3
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`SUPPL-4
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`11/27/2019
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`SUPPL-4
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`04/09/2019
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`SUPPL-1
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`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`E cacy-New Dosing
`Regimen
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209637s020s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209637Orig1s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209637s008lbl.pdf)
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209637s003lbl.pdf)
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209637s001lbl.pdf)
`
`12/05/2017
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf)
`
`Showing 1 to 11 of 11 entries
`
`Novo Nordisk Exhibit 2463
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`