`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020741
`Company: GEMINI LABS LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020741)
`
`Products on NDA 020741
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`PRANDIN
`
`REPAGLINIDE
`
`PRANDIN
`
`REPAGLINIDE
`
`PRANDIN
`
`REPAGLINIDE
`
`Showing 1 to 3 of 3 entries
`
`0.5MG **Federal Register determination that
`product was not discontinued or withdrawn for
`safety or effectiveness reasons**
`
`1MG **Federal Register determination that product
`was not discontinued or withdrawn for safety or
`effectiveness reasons**
`
`2MG **Federal Register determination that product
`was not discontinued or withdrawn for safety or
`effectiveness reasons**
`
`TABLET;ORAL
`
`Discontinued
`
`TABLET;ORAL
`
`Discontinued
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020741
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`12/22/1997
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Type 1 - New
`Molecular Entity
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`01/22/2019
`
`SUPPL-44
`
`02/08/2017
`
`SUPPL-42
`
`02/08/2017
`
`SUPPL-41
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`10/30/2015
`
`SUPPL-43
`
`Manufacturing (CMC)
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`PRIORITY
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020741Orig1s044ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020741Orig1s041,s042ltr.pdf)
`
`Label is not
`available on
`this site.
`
`03/01/2012
`
`SUPPL-40
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020741s040ltr.pdf)
`
`07/29/2010
`
`SUPPL-38
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020741s038ltr.pdf)
`
`Novo Nordisk Exhibit 2371
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`06/10/2009
`
`SUPPL-35
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020741s035ltr.pdf)
`
`07/14/2008
`
`SUPPL-34
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020741s034ltr.pdf)
`
`06/19/2006
`
`SUPPL-30
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020741s030LTR.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020741_S030_PRANDIN_TABS_AP.pdf)
`
`02/10/2005
`
`SUPPL-22
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20741s022ltr.pdf)
`
`10/15/2003
`
`SUPPL-19
`
`Manufacturing (CMC)-
`Packaging
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741scp019ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020741_S019_PRANDIN_TABS_AP.pdf)
`
`08/27/2003
`
`SUPPL-18
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20741slr018ltr.pdf)
`
`11/25/2002
`
`SUPPL-16
`
`Manufacturing (CMC)-
`Expiration Date
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S016_PRANDIN_TABS_AP.pdf)
`
`10/21/2002
`
`SUPPL-13
`
`E cacy-New Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741se1-013ltr.pdf)
`
`10/01/2002
`
`SUPPL-15
`
`08/05/2002
`
`SUPPL-14
`
`01/18/2002
`
`SUPPL-12
`
`10/27/2000
`
`SUPPL-10
`
`Manufacturing (CMC)-
`Control
`
`Manufacturing (CMC)-
`Expiration Date
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Manufacturing (CMC)-
`Control
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020741_S015_PRANDIN_TABS_AP.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20741s12ltr.pdf)
`
`08/15/2000
`
`SUPPL-9
`
`Manufacturing (CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020741_S009_PRANDIN_TABS_AP.pdf)
`
`02/25/2000
`
`SUPPL-8
`
`Manufacturing (CMC)
`
`12/08/1999
`
`SUPPL-6
`
`Manufacturing (CMC)
`
`11/26/1999
`
`SUPPL-7
`
`Manufacturing (CMC)-
`Control
`
`08/30/1999
`
`SUPPL-5
`
`Manufacturing (CMC)
`
`08/10/1999
`
`SUPPL-1
`
`Labeling
`
`05/18/1999
`
`SUPPL-4
`
`05/18/1999
`
`SUPPL-3
`
`Manufacturing (CMC)-
`Control
`
`Manufacturing (CMC)-
`Control
`
`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 2371
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing (CMC)-
`Expiration Date
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action Date
`
`Submission
`
`03/01/1999
`
`SUPPL-2
`
`Showing 1 to 27 of 27 entries
`
`Labels for NDA 020741
`
`Note
`
`Label is not
`available on
`this site.
`
`
`
`Novo Nordisk Exhibit 2371
`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): 020741
`Company: GEMINI LABS LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020741)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 020741
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020741
`
`Labels for NDA 020741
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`01/22/2019
`
`SUPPL-44
`
`02/08/2017
`
`SUPPL-42
`
`02/08/2017
`
`SUPPL-41
`
`03/01/2012
`
`SUPPL-40
`
`07/29/2010
`
`SUPPL-38
`
`06/10/2009
`
`SUPPL-35
`
`07/14/2008
`
`SUPPL-34
`
`02/10/2005
`
`SUPPL-22
`
`08/27/2003
`
`SUPPL-18
`
`10/21/2002
`
`SUPPL-13
`
`01/18/2002
`
`SUPPL-12
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`E cacy-New
`Indication
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020741s044lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020741s041s042lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020741s040lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020741s038lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020741s035lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020741s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20741s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20741slr018_prandin_lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s13lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20741s12lbl.pdf)
`
`12/22/1997
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/020741s044lbl.pdf)
`
`Showing 1 to 12 of 12 entries
`
`Novo Nordisk Exhibit 2371
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`