`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 017532
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=017532)
`
`Products on NDA 017532
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`DIABETA
`
`DIABETA
`
`DIABETA
`
`GLYBURIDE
`
`GLYBURIDE
`
`GLYBURIDE
`
`Showing 1 to 3 of 3 entries
`
`1.25MG
`
`2.5MG
`
`5MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`AB2
`
`AB2
`
`AB2
`
`Yes
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017532
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`RS
`
`No
`
`No
`
`Yes
`
`
`
`
`
`Action Date
`
`Submission
`
`Action Type
`
`Submission Classi cation
`
`Review Priority;
`Orphan Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`05/01/1984
`
`ORIG-1
`
`Approval
`
`Type 5 - New Formulation or New
`Manufacturer
`
`STANDARD
`
`Notes
`
`Label is not available
`on this site.
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`01/11/2017
`
`SUPPL-38
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017532s038lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017532Orig1s038ltr.pdf)
`
`08/25/2014
`
`SUPPL-36
`
`Manufacturing (CMC)
`
`10/15/2013
`
`SUPPL-34
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017532Orig1s034ltr.pdf)
`
`08/16/2013
`
`SUPPL-35
`
`Manufacturing (CMC)
`
`07/09/2009
`
`SUPPL-30
`
`03/05/2009
`
`SUPPL-28
`
`03/05/2009
`
`SUPPL-27
`
`Labeling
`
`Labeling
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s030ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf)
`
`Note
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2362
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`12/29/1999
`
`SUPPL-23
`
`Labeling
`
`10/08/1997
`
`SUPPL-22
`
`Manufacturing (CMC)
`
`02/20/1997
`
`SUPPL-21
`
`11/22/1996
`
`SUPPL-19
`
`03/29/1996
`
`SUPPL-20
`
`02/01/1995
`
`SUPPL-18
`
`Manufacturing (CMC)-
`Control
`
`Manufacturing (CMC)-
`Control
`
`Manufacturing (CMC)-
`Packaging
`
`Manufacturing (CMC)-
`Control
`
`08/11/1994
`
`SUPPL-17
`
`Labeling
`
`05/20/1994
`
`SUPPL-16
`
`Manufacturing (CMC)-
`Packaging
`
`07/27/1993
`
`SUPPL-15
`
`Labeling
`
`03/26/1993
`
`SUPPL-13
`
`03/26/1993
`
`SUPPL-10
`
`Manufacturing (CMC)-
`Packaging
`
`Manufacturing (CMC)-
`Control
`
`01/21/1993
`
`SUPPL-14
`
`Labeling
`
`08/06/1992
`
`SUPPL-12
`
`Labeling
`
`06/19/1992
`
`SUPPL-11
`
`Labeling
`
`04/27/1988
`
`SUPPL-9
`
`Labeling
`
`04/27/1988
`
`SUPPL-8
`
`Manufacturing (CMC)
`
`10/20/1987
`
`SUPPL-6
`
`10/20/1987
`
`SUPPL-5
`
`Manufacturing (CMC)-
`Control
`
`Manufacturing (CMC)-
`Control
`
`Note
`
`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.
`
`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.
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2362
`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
`
`08/27/1987
`
`SUPPL-7
`
`Labeling
`
`07/01/1986
`
`SUPPL-4
`
`Labeling
`
`03/27/1985
`
`SUPPL-2
`
`Manufacturing (CMC)-
`Formulation
`
`03/27/1985
`
`SUPPL-1
`
`Labeling
`
`01/04/1985
`
`SUPPL-3
`
`Manufacturing (CMC)-
`Packaging
`
`Showing 1 to 30 of 30 entries
`
`Labels for NDA 017532
`
`Therapeutic Equivalents for NDA 017532
`
`Note
`
`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 2362
`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): 017532
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=017532)
`
`Products on NDA 017532
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017532
`
`Labels for NDA 017532
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`01/11/2017
`
`SUPPL-38
`
`10/15/2013
`
`SUPPL-34
`
`07/09/2009
`
`SUPPL-30
`
`03/05/2009
`
`SUPPL-28
`
`03/05/2009
`
`SUPPL-27
`
`Showing 1 to 5 of 5 entries
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`Labeling
`
`Therapeutic Equivalents for NDA 017532
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017532s038lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf)
`
`
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2362
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 017532
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=017532)
`
`Products on NDA 017532
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017532
`
`Labels for NDA 017532
`
`Therapeutic Equivalents for NDA 017532
`
`DIABETA
`TABLET;ORAL; 1.25MG
`TE Code = AB2
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug
`Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`DIABETA
`
`GLYBURIDE
`
`1.25MG
`
`TABLET;ORAL
`
`Prescription
`
`GLYBURIDE
`
`GLYBURIDE
`
`1.25MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`No
`
`AB2
`
`AB2
`
`017532
`
`206079 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206079)
`
`SANOFI AVENTIS
`US
`
`IMPAX LABS INC
`
`Showing 1 to 2 of 2 entries
`
`TABLET;ORAL; 2.5MG
`TE Code = AB2
`
`CSV
`
`Excel
`
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`Strength
`
`2.5MG
`
`2.5MG
`
`Drug
`Name
`
`Active
`Ingredients
`
`DIABETA
`
`GLYBURIDE
`
`GLYBURIDE
`
`GLYBURIDE
`
`Showing 1 to 2 of 2 entries
`
`TABLET;ORAL; 5MG
`TE Code = AB2
`
`CSV
`
`Excel
`
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`No
`
`AB2
`
`AB2
`
`017532
`
`206079 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206079)
`
`SANOFI AVENTIS
`US
`
`IMPAX LABS INC
`
`Drug
`Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE Code
`
`Application No.
`
`Company
`
`DIABETA
`
`GLYBURIDE
`
`GLYBURIDE
`
`GLYBURIDE
`
`5MG
`
`5MG
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`No
`
`AB2
`
`AB2
`
`017532
`
`206079 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206079)
`
`SANOFI AVENTIS
`US
`
`IMPAX LABS INC
`
`Showing 1 to 2 of 2 entries
`
`Novo Nordisk Exhibit 2362
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`