`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021071
`Company: WOODWARD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021071)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf#page=38)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm)
`
`Products on NDA 021071
`
`CSV
`
`Excel
`
`
`Active Ingredients
`
`Strength
`
`Drug
`Name
`
`AVANDIA
`
`AVANDIA
`
`AVANDIA
`
`EQ 2MG BASE
`
`EQ 4MG BASE
`
`ROSIGLITAZONE
`MALEATE
`
`ROSIGLITAZONE
`MALEATE
`
`ROSIGLITAZONE
`MALEATE
`
`EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for
`safety or effectiveness reasons**
`
`TABLET;ORAL
`
`Discontinued
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TABLET;ORAL
`
`Discontinued
`
`TABLET;ORAL
`
`Discontinued
`
`TE
`Code
`
`None
`
`None
`
`None
`
`RLD
`
`RS
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`
`
`
`
`Showing 1 to 3 of 3 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021071
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`05/25/1999
`
`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/1999/21071lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21071ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21071_Avandia.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`02/05/2019
`
`SUPPL-52
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021071Orig1s052ltr.pdf)
`
`09/19/2016
`
`SUPPL-51
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021071Orig1s051ltr.pdf)
`
`12/16/2015
`
`SUPPL-50
`
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021071Orig1s050,021410Orig1s039,021700Orig1s022ltr.pdf)
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`05/07/2014
`
`SUPPL-49
`
`REMS-Assessment,
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf)
`
`Novo Nordisk Exhibit 2486
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`05/07/2014
`
`SUPPL-48
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021071Orig1s048.pdf)
`
`05/07/2014
`
`SUPPL-47
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021071Orig1s047,s048,s049ltr.pdf)
`
`09/16/2013
`
`SUPPL-45
`
`REMS-Assessment,
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s045,021410Orig1s034,021700Orig1s016ltr.pdf)
`
`01/25/2013
`
`SUPPL-44
`
`REMS-Modi ed
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021071Orig1s044,021410Orig1s032,021700Orig1s015ltr.pdf)
`
`05/30/2012
`
`SUPPL-41
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021071s041,021410s030,021700s013ltr.pdf)
`
`11/13/2011
`
`SUPPL-40
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s040,021410s029,021700s012ltr.pdf)
`
`05/18/2011
`
`SUPPL-39
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s039,021410s027,021700s011ltr.pdf)
`
`02/03/2011
`
`SUPPL-38
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021071s038,021410s026,021700s010ltr.pdf)
`
`10/20/2008
`
`SUPPL-34
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s034ltr.pdf)
`
`07/10/2008
`
`SUPPL-26
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s026ltr.pdf)
`
`02/22/2008
`
`SUPPL-32
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s032ltr.pdf)
`
`01/16/2008
`
`SUPPL-29
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021071s029ltr.pdf)
`
`11/14/2007
`
`SUPPL-31
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s031ltr.pdf)
`
`09/20/2007
`
`SUPPL-27
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s027ltr.pdf)
`
`08/14/2007
`
`SUPPL-28
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s028LTR.pdf)
`
`06/25/2007
`
`SUPPL-24
`
`Labeling
`
`04/23/2007
`
`SUPPL-23
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021071s023ltr.pdf)
`
`06/16/2006
`
`SUPPL-21
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf)
`
`06/16/2006
`
`SUPPL-19
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s019, 021071s021LTR.pdf)
`
`04/21/2006
`
`SUPPL-16
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021071s016LTR.pdf)
`
`07/29/2005
`
`SUPPL-15
`
`E cacy-New
`Patient Population
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s015ltr.pdf)
`
`05/12/2005
`
`SUPPL-10
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021071s010ltr.pdf)
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Novo Nordisk Exhibit 2486
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Action
`Date
`
`Submission
`
`02/28/2005
`
`SUPPL-12
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s012ltr.pdf)
`
`01/04/2005
`
`SUPPL-14
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21071s014,21410s009ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021071_s014_Avandia Tabs.pdf)
`
`05/19/2004
`
`SUPPL-9
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21071slr009,21410slr005,006ltr.pdf)
`
`02/27/2003
`
`SUPPL-4
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21071se1-004ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021071_S004_AVANDIA.pdf)
`
`12/03/2002
`
`SUPPL-8
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21071slr008ltr.pdf)
`
`02/08/2001
`
`SUPPL-6
`
`Labeling
`
`12/13/2000
`
`SUPPL-7
`
`Manufacturing
`(CMC)-Control
`
`12/05/2000
`
`SUPPL-5
`
`Labeling
`
`07/11/2000
`
`SUPPL-2
`
`Labeling
`
`07/03/2000
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`04/03/2000
`
`SUPPL-1
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21071S1LTR.PDF)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia.cfm)
`
`Showing 1 to 37 of 37 entries
`
`Labels for NDA 021071
`
`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.
`
`
`
`Novo Nordisk Exhibit 2486
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`
`
`
`
`
`
`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): 021071
`Company: WOODWARD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021071)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf#page=38)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm)
`
`Products on NDA 021071
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021071
`
`Labels for NDA 021071
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`02/05/2019
`
`SUPPL-52
`
`09/19/2016
`
`SUPPL-51
`
`05/07/2014
`
`SUPPL-49
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`REMS-
`Assessment
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021071s052lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021071s051lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`
`05/07/2014
`
`SUPPL-49
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`
`05/07/2014
`
`SUPPL-48
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`
`05/07/2014
`
`SUPPL-47
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021071s047s048s049lbl.pdf)
`
`05/30/2012
`
`SUPPL-41
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021071s041lbl.pdf)
`
`11/13/2011
`
`SUPPL-40
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040lbl.pdf)
`
`05/18/2011
`
`SUPPL-39
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s039lbl.pdf)
`
`02/03/2011
`
`SUPPL-38
`
`10/20/2008
`
`SUPPL-34
`
`07/10/2008
`
`SUPPL-26
`
`02/22/2008
`
`SUPPL-32
`
`01/16/2008
`
`SUPPL-29
`
`11/14/2007
`
`SUPPL-31
`
`09/20/2007
`
`SUPPL-27
`
`08/14/2007
`
`SUPPL-28
`
`04/23/2007
`
`SUPPL-23
`
`06/16/2006
`
`SUPPL-21
`
`06/16/2006
`
`SUPPL-19
`
`Labeling
`
`Labeling
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s038,021410s026,021700s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s032lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021071s029lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021071s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s019s021lbl.pdf)
`
`Novo Nordisk Exhibit 2486
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Action
`Date
`
`Submission
`
`04/21/2006
`
`SUPPL-16
`
`07/29/2005
`
`SUPPL-15
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-New
`Patient
`Population
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021071s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s015lbl.pdf)
`
`05/12/2005
`
`SUPPL-10
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021071s010lbl.pdf)
`
`02/28/2005
`
`SUPPL-12
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s012lbl.pdf)
`
`01/04/2005
`
`SUPPL-14
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/21071s014lbl.pdf)
`
`02/27/2003
`
`SUPPL-4
`
`04/03/2000
`
`SUPPL-1
`
`E cacy-New
`Indication
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021071s004lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-071S001_Avandia_prntlbl.pdf)
`
`05/25/1999
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21071lbl.pdf)
`
`Showing 1 to 28 of 28 entries
`
`Novo Nordisk Exhibit 2486
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`