`
`Drugs@FDA: FDA-Approved Drugs
`
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`New Drug Application (NDA): 017783
`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=017783)
`
`Products on NDA 017783
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`GLUCOTROL
`
`GLUCOTROL
`
`GLUCOTROL
`
`GLIPIZIDE
`
`GLIPIZIDE
`
`GLIPIZIDE
`
`Showing 1 to 3 of 3 entries
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`5MG
`
`10MG
`
`2.5MG **Federal Register determination that
`product was not discontinued or withdrawn for
`safety or effectiveness reasons**
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Discontinued
`
`Discontinued
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`Discontinued
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`None
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`None
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`None
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`Yes
`
`Yes
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`Yes
`
`No
`
`No
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017783
`
`Original Approvals or Tentative Approvals
`
`CSV
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`Excel
`
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`Action Date
`
`Submission
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`Action Type
`
`Submission Classi cation
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`Review Priority;
`Orphan Status
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`Letters, Reviews,
`Labels, Patient
`Package Insert
`
`05/08/1984
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`ORIG-1
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`Approval
`
`Type 1 - New Molecular Entity
`
`STANDARD
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`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
`
`08/18/2016
`
`SUPPL-26
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017783Orig1s026ltr.pdf)
`
`10/15/2013
`
`SUPPL-25
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf)
`
`02/07/2011
`
`SUPPL-21
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf)
`
`08/27/2009
`
`SUPPL-20
`
`10/27/2008
`
`SUPPL-19
`
`12/15/1999
`
`SUPPL-16
`
`Labeling
`
`Labeling
`
`Manufacturing (CMC)-
`Packaging
`
`08/06/1999
`
`SUPPL-15
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf)
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2364
`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
`
`12/11/1997
`
`SUPPL-14
`
`Manufacturing (CMC)
`
`11/24/1993
`
`SUPPL-13
`
`Manufacturing (CMC)
`
`05/19/1993
`
`SUPPL-12
`
`Labeling
`
`05/11/1993
`
`SUPPL-11
`
`Manufacturing (CMC)-
`Formulation
`
`08/06/1991
`
`SUPPL-10
`
`Manufacturing (CMC)
`
`05/14/1987
`
`SUPPL-9
`
`Manufacturing (CMC)
`
`03/31/1987
`
`SUPPL-8
`
`Labeling
`
`03/04/1987
`
`SUPPL-6
`
`Manufacturing (CMC)-
`Packaging
`
`09/15/1986
`
`SUPPL-7
`
`Manufacturing (CMC)
`
`11/18/1985
`
`SUPPL-4
`
`Labeling
`
`10/22/1985
`
`SUPPL-3
`
`Manufacturing (CMC)-
`Expiration Date
`
`10/16/1985
`
`SUPPL-5
`
`Manufacturing (CMC)
`
`03/15/1985
`
`SUPPL-2
`
`Manufacturing (CMC)-
`Formulation
`
`Showing 1 to 20 of 20 entries
`
`Labels for NDA 017783
`
`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.
`
`
`
`Novo Nordisk Exhibit 2364
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 017783
`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=017783)
`
`Products on NDA 017783
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 017783
`
`Labels for NDA 017783
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`08/18/2016
`
`SUPPL-26
`
`10/15/2013
`
`SUPPL-25
`
`02/07/2011
`
`SUPPL-21
`
`08/27/2009
`
`10/27/2008
`
`SUPPL-20
`
`SUPPL-19
`
`Showing 1 to 5 of 5 entries
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf)
`
`
`
`
`
`
`
`Note
`
`Novo Nordisk Exhibit 2364
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`