`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021073
`Company: TAKEDA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021073)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35)
`
`Products on NDA 021073
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`ACTOS
`
`ACTOS
`
`ACTOS
`
`PIOGLITAZONE HYDROCHLORIDE
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`PIOGLITAZONE HYDROCHLORIDE
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`PIOGLITAZONE HYDROCHLORIDE
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`Yes
`
`Showing 1 to 3 of 3 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021073
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/15/1999
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Type 1 - New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`PRIORITY
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21073ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021073A_Actos.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`12/21/2017
`
`SUPPL-49
`
`12/12/2016
`
`SUPPL-48
`
`11/12/2013
`
`SUPPL-46
`
`06/27/2013
`
`SUPPL-47
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021073Orig1s049ltr.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021073Orig1s048ltr.pdf)
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021073Orig1s046ltr.pdf)
`
`Manufacturing
`(CMC)
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Novo Nordisk Exhibit 2485
`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
`
`05/17/2012
`
`SUPPL-45
`
`REMS-Assessment
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021073s045,021842s016,022024s009,021925s012ltr.pdf)
`
`08/04/2011
`
`SUPPL-44
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-
`022024Orig1s008s007-021925Orig1s010s011ltr.pdf )
`
`08/04/2011
`
`SUPPL-43
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021073Orig1s043s044-021842Orig1s014s015-
`022024Orig1s008s007-021925Orig1s010s011ltr.pdf )
`
`02/03/2011
`
`SUPPL-35
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf)
`
`07/29/2010
`
`SUPPL-40
`
`Labeling-
`Container/Carton
`Labels
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021073s040ltr.pdf)
`
`09/09/2009
`
`SUPPL-37
`
`Labeling, REMS-
`Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021073s037ltr.pdf)
`
`12/11/2008
`
`SUPPL-34
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s034ltr.pdf)
`
`05/07/2008
`
`SUPPL-33
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021073s033ltr.pdf)
`Patient Package Insert (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s033PI.pdf)
`
`09/06/2007
`
`SUPPL-30
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s030_ltr.pdf)
`
`08/14/2007
`
`SUPPL-31
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s031LTR.pdf)
`
`02/25/2007
`
`SUPPL-26
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021073s026ltr.pdf)
`
`11/04/2006
`
`SUPPL-28
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073S028, 021842S002ltr.pdf)
`
`09/28/2006
`
`SUPPL-29
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s029, 021842s003LTR.pdf)
`
`08/30/2006
`
`SUPPL-27
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021073s027ltr.pdf)
`
`08/03/2004
`
`SUPPL-23
`
`Labeling
`
`07/20/2004
`
`SUPPL-24
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s023ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s023_ACTOS TABS.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21073s024ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021073_s024_ACTOS TABS.pdf)
`
`11/26/2003
`
`SUPPL-20
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-020ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021073_S020_ACTOS TABLETS_AP.pdf)
`
`06/11/2003
`
`SUPPL-21
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073slr071ltr.pdf)
`
`01/17/2003
`
`SUPPL-17
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21073se8-017ltr.pdf)
`
`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 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Action
`Date
`
`Submission
`
`12/03/2002
`
`SUPPL-18
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing
`(CMC)-Packaging
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073scp018ltr.pdf)
`
`10/01/2002
`
`SUPPL-13
`
`Manufacturing
`(CMC)-Control
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S013_ACTOS_TABLETS.pdf)
`
`07/12/2002
`
`SUPPL-10
`
`02/28/2002
`
`SUPPL-15
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Manufacturing
`(CMC)-Control
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073se8010ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S010_Actos Tablets_APPROVAL PACKAGE.pdf)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S015_ACTOS_TABLETS.pdf)
`
`01/07/2002
`
`SUPPL-16
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21073s16ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021073_S016_ACTOS.pdf)
`
`08/03/2001
`
`SUPPL-14
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S014_ACTOS.pdf)
`
`07/06/2001
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`07/06/2001
`
`SUPPL-8
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S008_ACTOS TABLETS.pdf)
`
`07/02/2001
`
`SUPPL-11
`
`Labeling
`
`05/22/2001
`
`SUPPL-12
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S012_ACTOS TABLETS.pdf)
`
`04/25/2001
`
`SUPPL-7
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/021073_S007_ACTOS.pdf)
`
`11/03/2000
`
`SUPPL-6
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S006_ACTOS.pdf)
`
`10/25/2000
`
`SUPPL-4
`
`Manufacturing
`(CMC)-Control
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S004_ACTOS.pdf)
`
`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.
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action
`Date
`
`Submission
`
`07/26/2000
`
`SUPPL-5
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S005_ACTOS.pdf)
`
`04/11/2000
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S003_ACTOS.pdf)
`
`02/25/2000
`
`SUPPL-2
`
`Manufacturing
`(CMC)-Control
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S002_ACTOS.pdf)
`
`02/25/2000
`
`SUPPL-1
`
`Manufacturing
`(CMC)-Packaging
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/021073_S001_ACTOS.pdf)
`
`Showing 1 to 40 of 40 entries
`
`Labels for NDA 021073
`
`Therapeutic Equivalents for NDA 021073
`
`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.
`
`
`
`
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`
`
`
`
`
`
`Note
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021073
`Company: TAKEDA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021073)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35)
`
`Products on NDA 021073
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021073
`
`Labels for NDA 021073
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`12/21/2017
`
`SUPPL-49
`
`12/12/2016
`
`SUPPL-48
`
`11/12/2013
`
`SUPPL-46
`
`08/04/2011
`
`SUPPL-44
`
`08/04/2011
`
`SUPPL-44
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021073s048lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021073s046lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf)
`
`08/04/2011
`
`SUPPL-43
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf)
`
`02/03/2011
`
`SUPPL-35
`
`09/09/2009
`
`SUPPL-37
`
`Labeling
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s035lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf)
`
`09/09/2009
`
`SUPPL-37
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021073s037lbl.pdf)
`
`12/11/2008
`
`SUPPL-34
`
`09/06/2007
`
`SUPPL-30
`
`08/14/2007
`
`SUPPL-31
`
`02/25/2007
`
`SUPPL-26
`
`11/04/2006
`
`SUPPL-28
`
`08/30/2006
`
`SUPPL-27
`
`08/03/2004
`
`SUPPL-23
`
`07/20/2004
`
`SUPPL-24
`
`11/26/2003
`
`SUPPL-20
`
`Labeling
`
`Labeling
`
`Labeling
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021073s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s030lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021073s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s028,021842s002lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021073s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21073s024lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073se8-020_actos_lbl.pdf)
`
`06/11/2003
`
`SUPPL-21
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21073slr071_actos_lbl.pdf)
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`
`
`Action Date
`
`Submission
`
`07/12/2002
`
`SUPPL-10
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21073s10lbl.pdf)
`
`07/15/1999
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21073lbl.pdf)
`
`Showing 1 to 21 of 21 entries
`
`Therapeutic Equivalents for NDA 021073
`
`Note
`
`
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00006
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021073
`Company: TAKEDA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021073)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021073s049lbl.pdf#page=35)
`
`Products on NDA 021073
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021073
`
`Labels for NDA 021073
`
`Therapeutic Equivalents for NDA 021073
`
`
`
`
`
`
`
`
`
`ACTOS
`TABLET;ORAL; EQ 15MG BASE
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`ACTOS
`
`Active
`Ingredients
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`021073
`
`200044 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200044)
`
`204133 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=204133)
`
`200268 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200268)
`
`076798 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=076798)
`
`TAKEDA PHARMS
`USA
`
`ACCORD HLTHCARE
`
`ANNORA PHARMA
`
`AUROBINDO
`PHARMA LTD
`
`CHARTWELL RX
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Showing 1 to 12 of 12 entries
`
`TABLET;ORAL; EQ 30MG BASE
`TE Code = AB
`
`CSV
`
`Excel
`
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 15MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`202467 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202467)
`
`207806 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=207806)
`
`MACLEODS
`PHARMS LTD
`
`PRINSTON INC
`
`206738 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206738)
`
`PURACAP PHARM
`LLC
`
`078670 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078670)
`
`SANDOZ
`
`210165 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=210165)
`
`SHUANGCHENG
`
`077210 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077210)
`
`TEVA PHARMS USA
`
`202456 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202456)
`
`ZYDUS PHARMS
`USA INC
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00007
`
`
`
`Drug Name
`
`ACTOS
`
`Active
`Ingredients
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`021073
`
`200044 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200044)
`
`204133 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=204133)
`
`200268 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200268)
`
`076798 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=076798)
`
`TAKEDA PHARMS
`USA
`
`ACCORD HLTHCARE
`
`ANNORA PHARMA
`
`AUROBINDO
`PHARMA LTD
`
`CHARTWELL RX
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`EQ 30MG BASE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 30MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`202467 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202467)
`
`207806 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=207806)
`
`MACLEODS
`PHARMS LTD
`
`PRINSTON INC
`
`206738 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206738)
`
`PURACAP PHARM
`LLC
`
`078670 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078670)
`
`SANDOZ
`
`210165 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=210165)
`
`SHUANGCHENG
`
`077210 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077210)
`
`TEVA PHARMS USA
`
`202456 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202456)
`
`ZYDUS PHARMS
`USA INC
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Showing 1 to 12 of 12 entries
`
`TABLET;ORAL; EQ 45MG BASE
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`ACTOS
`
`Active
`Ingredients
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`021073
`
`200044 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200044)
`
`204133 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=204133)
`
`200268 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=200268)
`
`TAKEDA PHARMS
`USA
`
`ACCORD HLTHCARE
`
`ANNORA PHARMA
`
`AUROBINDO
`PHARMA LTD
`
`CHARTWELL RX
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`076798 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=076798)
`
`202467 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202467)
`
`207806 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=207806)
`
`MACLEODS
`PHARMS LTD
`
`PRINSTON INC
`
`206738 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=206738)
`
`PURACAP PHARM
`LLC
`
`078670 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078670)
`
`SANDOZ
`
`210165 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=210165)
`
`077210 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077210)
`
`SHUANGCHENG
`
`TEVA PHARMS USA
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00008
`
`
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`PIOGLITAZONE
`HYDROCHLORIDE
`
`Showing 1 to 12 of 12 entries
`
`EQ 45MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`AB
`
`202456 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202456)
`
`ZYDUS PHARMS
`USA INC
`
`Novo Nordisk Exhibit 2485
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00009
`
`