`
`Drugs@FDA: FDA-Approved Drugs
`
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`New Drug Application (NDA): 017498
`Company: PFIZER
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=017498)
`
`Products on NDA 017498
`
`CSV
`
`Excel
`
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`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`MICRONASE
`
`GLYBURIDE
`
`MICRONASE
`
`MICRONASE
`
`GLYBURIDE
`
`GLYBURIDE
`
`Showing 1 to 3 of 3 entries
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`1.25MG **Federal Register determination that
`product was not discontinued or withdrawn for
`safety or effectiveness reasons**
`
`2.5MG
`
`5MG **Federal Register determination that
`product was not discontinued or withdrawn for
`safety or effectiveness reasons**
`
`TABLET;ORAL
`
`Discontinued
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Discontinued
`
`Discontinued
`
`None
`
`None
`
`None
`
`Yes
`
`No
`
`Yes
`
`No
`
`No
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017498
`
`Original Approvals or Tentative Approvals
`
`CSV
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`Excel
`
`
`Action Date
`
`Submission
`
`Action Type
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`Submission Classi cation
`
`Review Priority;
`Orphan Status
`
`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`05/01/1984
`
`ORIG-1
`
`Approval
`
`Type 1 - New Molecular Entity
`
`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
`
`Note
`
`05/22/2015
`
`SUPPL-32
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017498Orig1s032ltr.pdf)
`
`10/15/2013
`
`SUPPL-31
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017498Orig1s031ltr.pdf)
`
`02/01/2011
`
`SUPPL-30
`
`08/27/2009
`
`SUPPL-29
`
`10/27/2008
`
`SUPPL-27
`
`Labeling
`
`Labeling
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017498s030ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017498s029ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017498s027ltr.pdf)
`
`11/30/1999
`
`SUPPL-23
`
`Manufacturing (CMC)
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2363
`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
`
`10/28/1999
`
`SUPPL-21
`
`Labeling
`
`06/27/1997
`
`SUPPL-20
`
`Manufacturing (CMC)-
`Control
`
`04/02/1997
`
`SUPPL-19
`
`Labeling
`
`04/02/1997
`
`SUPPL-18
`
`Labeling
`
`09/28/1995
`
`SUPPL-16
`
`Manufacturing (CMC)-
`Packaging
`
`09/28/1995
`
`SUPPL-15
`
`Manufacturing (CMC)
`
`01/21/1993
`
`SUPPL-14
`
`Labeling
`
`07/27/1992
`
`SUPPL-13
`
`Labeling
`
`11/15/1991
`
`SUPPL-11
`
`Manufacturing (CMC)-
`Control
`
`12/14/1990
`
`SUPPL-12
`
`Labeling
`
`04/27/1988
`
`SUPPL-10
`
`Manufacturing (CMC)
`
`03/02/1988
`
`SUPPL-8
`
`Manufacturing (CMC)-
`Control
`
`01/05/1988
`
`SUPPL-9
`
`Labeling
`
`06/25/1987
`
`SUPPL-7
`
`Labeling
`
`04/07/1987
`
`SUPPL-6
`
`Labeling
`
`03/24/1986
`
`SUPPL-5
`
`Labeling
`
`03/18/1986
`
`SUPPL-4
`
`Manufacturing (CMC)
`
`07/24/1985
`
`SUPPL-2
`
`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 2363
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing (CMC)-
`Control
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action Date
`
`Submission
`
`01/15/1985
`
`SUPPL-1
`
`Showing 1 to 25 of 25 entries
`
`Labels for NDA 017498
`
`Note
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2363
`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): 017498
`Company: PFIZER
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=017498)
`
`Products on NDA 017498
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017498
`
`Labels for NDA 017498
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`05/22/2015
`
`SUPPL-32
`
`10/15/2013
`
`SUPPL-31
`
`02/01/2011
`
`08/27/2009
`
`10/27/2008
`
`SUPPL-30
`
`SUPPL-29
`
`SUPPL-27
`
`Showing 1 to 5 of 5 entries
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`Labeling
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf)
`
`
`
`
`
`
`
`Note
`
`Novo Nordisk Exhibit 2363
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`