IPR2015-01340, No. 2120-68 Exhibit - AstraZeneca Exhibit 2120 (P.T.A.B. Aug. 3, 2016)

2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`FDA Home3 Drug Databases4 Drugs@FDA5
`
`
`
`
`
`Label and Approval History
`
`AMARYL
`Drug Name(s)
`FDA Application No. (NDA) 020496
`Active Ingredient(s) GLIMEPIRIDE
`Company
`SANOFI AVENTIS US
`
`FAQ6  |  Instructions7  |   Glossary8  |   Contact Us9
`
`Email Link
`
`Label Information
`
`Go to Approval History
`
`What information does a label include?10
`Note: Not all labels are available in electronic format from FDA.
`View the label approved on 10/15/2013 (PDF)11 for NDA no. 020496
`To see older, previouslyapproved labels, go to the "Approval History" section of this page. Older labels
`are for historical information only and should not be used for clinical purposes.
`Approval History
`NDA 020496
`
`Note: Not all reviews are available in electronic format from FDA.
`Older labels are for historical information only, and should not be used for clinical purposes.
`Approval dates can only be verified from 1984 to the present.
`
`Click on a column header to resort the table:
`
`Action
`Date
`
`SupplementApproval
`
`Number
`Type
`
`10/15/2013 027
`
`Labeling Revision
`
`08/01/2013 026
`
`Labeling Revision
`
`04/19/2013 025
`
`Manufacturing Change or Addition
`
`Letters,
`Reviews,
`Labels,
`Patient Package
`Insert
`Label (PDF)12
`Letter (PDF)13
`Label (PDF)14
`Letter (PDF)15
`
`
`03/14/2013 024
`
`Manufacturing Change or Addition
`
`
`
`02/03/2012 022
`
`Labeling Revision
`
`06/04/2009 021
`
`Labeling Revision
`
`02/03/2009 019
`
`Labeling Revision
`
`02/03/2009 018
`
`Labeling Revision
`
`11/28/2005 015
`
`Patient Population Altered
`
`09/19/2005 016
`
`Labeling Revision
`
`08/16/2004 013
`
`Labeling Revision
`
`04/15/2002 007
`
`Labeling Revision
`
`Label (PDF)16
`Letter (PDF)17
`Label (PDF)18
`Letter (PDF)19
`Label (PDF)20
`Letter (PDF)21
`Label (PDF)22
`Letter (PDF)23
`Label (PDF)24
`Letter (PDF)25
`Label (PDF)26
`Letter (PDF)27
`Letter (PDF)28
`
`Letter (PDF)29
`
` Download data
`
`Note
`
`
`
`
`
`This supplement type does
`not usually require new labeling.
`This supplement type does
`not usually require new labeling.
`
`
`
`
`
`
`
`
`
`
`
`
`Label is not available
`on this site.
`Label is not available
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`1/6
`
`AstraZeneca Exhibit 2120
`Mylan v. AstraZeneca
`IPR2015-01340
`
`Page 1 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`07/21/2001 011
`
`Manufacturing Change or Addition
`
`12/05/2000 010
`
`Control Supplement
`
`
`
`
`
`09/27/2000 005
`
`08/29/2000 009
`
`Efficacy Supplement with Clinical Data to
`Support
`Control Supplement
`
`01/06/2000 006
`
`Manufacturing Change or Addition
`
`02/24/1999 002
`
`New or Modified Indication
`
`09/16/1998 004
`
`Package Change
`
`09/16/1998 003
`
`Package Change
`
`07/28/1997 001
`
`Manufacturing Change or Addition
`
`11/30/1995 000
`
`Approval
`
`Review (PDF)30
`
`
`
`
`
`Letter (PDF)31
`Review 32
`
`
`
`
`
`
`
`
`on this site.
`This supplement type does
`not usually require new labeling.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`Label is not available
`on this site.
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and
`Players33
`
`Therapeutic Equivalents
`
`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
`Disclaimer34
`
`FDA/Center for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Daily
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079846.htm
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
`12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
`13. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf
`14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf
`15. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf
`16. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf
`17. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf
`18. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`2/6
`
`Page 2 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`19. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf
`20. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
`21. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
`22. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
`23. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
`24. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf
`25. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf
`26. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf
`27. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf
`28. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf
`29. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf
`30. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496S005_Amaryl.pdf
`31. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf
`32. http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm
`33. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`34. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`35. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`36. http://www.fda.gov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
`37. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`38. http://www.fda.gov/AboutFDA/WorkingatFDA/default.htm
`39. http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm
`40. http://www.fda.gov/RegulatoryInformation/FOI/default.htm
`41. http://www.fda.gov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
`42. http://www.fda.gov/SiteMap/default.htm
`43. http://www.fda.gov/AboutFDA/Transparency/default.htm
`44. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
`45. http://www.fda.gov
`46. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`47. http://www.usa.gov
`48. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
`49. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
`50. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#micro
`51. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#Facebook
`52. http://www.fda.gov/NewsEvents/InteractiveMedia/ucm200145.htm
`53. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#flickr
`54. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`55. http://www.fda.gov/NewsEvents/default.htm
`56. http://www.fda.gov/CombinationProducts/default.htm
`57. http://www.fda.gov/AdvisoryCommittees/default.htm
`58. http://www.fda.gov/ScienceResearch/default.htm
`59. http://www.fda.gov/RegulatoryInformation/default.htm
`60. http://www.fda.gov/Safety/default.htm
`61. http://www.fda.gov/EmergencyPreparedness/default.htm
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`3/6
`
`Page 3 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`62. http://www.fda.gov/InternationalPrograms/default.htm
`63. http://www.fda.gov/NewsEvents/default.htm
`64. http://www.fda.gov/Training/default.htm
`65. http://www.fda.gov/ICECI/default.htm
`66. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`67. http://www.fda.gov/ForConsumers/default.htm
`68. http://www.fda.gov/ForIndustry/default.htm
`69. http://www.fda.gov/ForHealthProfessionals/default.htm
`70. http://www.accessdata.fda.gov/scripts/search/index.cfm?action=archive.search
`71. http://www.hhs.gov
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players35
`Accessibility36 Contact FDA37 Careers38 FDA Basics39 FOIA40 No Fear Act41 Site Map42 Transparency43 Website
`Policies44
`
`45
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1888INFOFDA (18884636332)
`Contact FDA46
`
`51
`
`52
`
`50
`49
`48
`47
`For Government54 For Press55
`Combination Products56 Advisory Committees57 Science & Research58 Regulatory Information59 Safety60 Emergency
`Preparedness61 International Programs62 News & Events63 Training and Continuing Education64
`Inspections/Compliance65 State & Local Officials66 Consumers67 Industry68 Health Professionals69 FDA Archive70
`
`53
`
`71
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079846.htm
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
`12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf
`13. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf
`14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf
`15. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf
`16. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf
`17. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf
`18. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf
`19. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`4/6
`
`Page 4 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`20. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
`21. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
`22. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf
`23. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf
`24. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf
`25. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf
`26. http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf
`27. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf
`28. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf
`29. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf
`30. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496S005_Amaryl.pdf
`31. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf
`32. http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm
`33. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`34. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`35. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`36. http://www.fda.gov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
`37. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`38. http://www.fda.gov/AboutFDA/WorkingatFDA/default.htm
`39. http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm
`40. http://www.fda.gov/RegulatoryInformation/FOI/default.htm
`41. http://www.fda.gov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
`42. http://www.fda.gov/SiteMap/default.htm
`43. http://www.fda.gov/AboutFDA/Transparency/default.htm
`44. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
`45. http://www.fda.gov
`46. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`47. http://www.usa.gov
`48. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
`49. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
`50. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#micro
`51. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#Facebook
`52. http://www.fda.gov/NewsEvents/InteractiveMedia/ucm200145.htm
`53. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#flickr
`54. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`55. http://www.fda.gov/NewsEvents/default.htm
`56. http://www.fda.gov/CombinationProducts/default.htm
`57. http://www.fda.gov/AdvisoryCommittees/default.htm
`58. http://www.fda.gov/ScienceResearch/default.htm
`59. http://www.fda.gov/RegulatoryInformation/default.htm
`60. http://www.fda.gov/Safety/default.htm
`61. http://www.fda.gov/EmergencyPreparedness/default.htm
`62. http://www.fda.gov/InternationalPrograms/default.htm
`63. http://www.fda.gov/NewsEvents/default.htm
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`5/6
`
`Page 5 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`64. http://www.fda.gov/Training/default.htm
`65. http://www.fda.gov/ICECI/default.htm
`66. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`67. http://www.fda.gov/ForConsumers/default.htm
`68. http://www.fda.gov/ForIndustry/default.htm
`69. http://www.fda.gov/ForHealthProfessionals/default.htm
`70. http://www.accessdata.fda.gov/scripts/search/index.cfm?action=archive.search
`71. http://www.hhs.gov
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`6/6
`
`Page 6 of 77
`
`

`
`2/21/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`FDA Home3 Drug Databases4 Drugs@FDA5
`
`
`
`Drug Details
`
`FAQ6  |  Instructions7  |   Glossary8  |   Contact Us9
`
`Email Link
`
`Drug Name(s)
`FDA Application No.
`Active Ingredient(s)
`Company
`Original Approval or Tentative Approval Date
`Chemical Type
`Review Classification
`
`AVANDIA
`(NDA) 021071
`ROSIGLITAZONE MALEATE
`SB PHARMCO
`May 25, 1999
`1  New molecular entity (NME)
`P  Priority review drug
`
`Therapeutic Equivalents
`
`Label Information
`
`Approval History, Letters, Reviews, and Related
`Documents
`
`Other Important Information from FDA 10
`
`Medication Guide11
`
`Products on Application (NDA) #021071
`    Click on a column header to resort the table:
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`AVANDIA
`AVANDIA
`AVANDIA
`
`ROSIGLITAZONE MALEATE
`ROSIGLITAZONE MALEATE
`ROSIGLITAZONE MALEATE
`
`EQ 2MG BASE
`EQ 4MG BASE
`EQ 8MG BASE
`
`TABLET;ORAL
`TABLET;ORAL
`TABLET;ORAL
`
`Marketing
`Status
`Prescription
`Prescription
`Prescription
`
`RLD TE
`Code
`AB
`No
`AB
`No
`Yes AB
`
`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
`Disclaimer12
`
`FDA/Center for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Daily
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
`
`1/2
`
`Page 7 of 77
`
`

`
`2/21/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040MedG.pdf
`12. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1888INFOFDA (18884636332)
`Contact FDA
`
`
`
`
`
`
`
`
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness
`International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials
`Consumers Industry Health Professionals FDA Archive
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm143349.htm
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021071s040MedG.pdf
`12. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails
`
`2/2
`
`Page 8 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`FDA Home3 Drug Databases4 Drugs@FDA5
`
`
`
`
`
`
`
`Label and Approval History
`
`GLUCOTROL
`Drug Name(s)
`FDA Application No. (NDA) 017783
`Active Ingredient(s) GLIPIZIDE
`Company
`PFIZER
`
`FAQ6  |  Instructions7  |   Glossary8  |   Contact Us9
`
`Email Link
`
`Label Information
`
`Go to Approval History
`
`What information does a label include?10
`Note: Not all labels are available in electronic format from FDA.
`View the label approved on 10/15/2013 (PDF)11 for NDA no. 017783
`To see older, previouslyapproved labels, go to the "Approval History" section of this page. Older labels
`are for historical information only and should not be used for clinical purposes.
`Approval History
`NDA 017783
`
`Note: Not all reviews are available in electronic format from FDA.
`Older labels are for historical information only, and should not be used for clinical purposes.
`Approval dates can only be verified from 1984 to the present.
`
`Click on a column header to resort the table:
`
` Download data
`
`Action
`Date
`
`Supplement
`Number
`
`Approval
`Type
`
`10/15/2013 025
`
`Labeling Revision
`
`02/07/2011 021
`
`Labeling Revision
`
`08/27/2009 020
`
`Labeling Revision
`
`10/27/2008 019
`
`Packaging Addition
`
`12/15/1999 016
`
`Package Change
`
`Letters,
`Reviews,
`Labels,
`Patient Package Insert
`Label (PDF)12
`Letter (PDF)13
`Label (PDF)14
`Letter (PDF)15
`Label (PDF)16
`Letter (PDF)17
`Label (PDF)18
`Letter (PDF)19
`
`
`08/06/1999 015
`
`Labeling Revision
`
`
`
`12/11/1997 014
`
`Manufacturing Change or Addition
`
`11/24/1993 013
`
`Manufacturing Change or Addition
`
`05/19/1993 012
`
`Labeling Revision
`
`05/11/1993 011
`
`Formulation Revision
`
`
`
`
`
`08/06/1991 010
`
`Manufacturing Change or Addition
`
`05/14/1987 009
`
`Manufacturing Change or Addition
`
`03/31/1987 008
`
`Final Printed Labeling MarkIV
`
`
`
`Note
`
`
`
`
`
`
`
`
`
`Label is not available
`on this site.
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`1/5
`
`Page 9 of 77
`
`

`
`2/14/2016
`03/04/1987 006
`
`Package Change
`
`Drugs@FDA: FDA Approved Drug Products
`
`
`09/15/1986 007
`
`Manufacturing Change or Addition
`
`11/18/1985 004
`
`Labeling Revision
`
`10/22/1985 003
`
`Expiration Date Change
`
`
`
`
`
`10/16/1985 005
`
`Manufacturing Change or Addition
`
`03/15/1985 002
`
`Formulation Revision
`
`05/08/1984 000
`
`Approval
`
`
`
`
`
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`Label is not available
`on this site.
`This supplement type does
`not usually require new labeling.
`Label is not available
`on this site.
`Label is not available
`on this site.
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and
`Players20
`
`Therapeutic Equivalents
`
`Back to Top | Back to Previous Page | Back to Drugs@FDA Home
`Disclaimer21
`
`FDA/Center for Drug Evaluation and Research
`Office of Communications
`Division of Online Communications
`Update Frequency: Daily
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079846.htm
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
`12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
`13. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf
`14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf
`15. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf
`16. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf
`17. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf
`18. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf
`19. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf
`20. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`21. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`22. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`23. http://www.fda.gov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`2/5
`
`Page 10 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`24. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`25. http://www.fda.gov/AboutFDA/WorkingatFDA/default.htm
`26. http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm
`27. http://www.fda.gov/RegulatoryInformation/FOI/default.htm
`28. http://www.fda.gov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
`29. http://www.fda.gov/SiteMap/default.htm
`30. http://www.fda.gov/AboutFDA/Transparency/default.htm
`31. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
`32. http://www.fda.gov
`33. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`34. http://www.usa.gov
`35. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
`36. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
`37. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#micro
`38. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#Facebook
`39. http://www.fda.gov/NewsEvents/InteractiveMedia/ucm200145.htm
`40. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#flickr
`41. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`42. http://www.fda.gov/NewsEvents/default.htm
`43. http://www.fda.gov/CombinationProducts/default.htm
`44. http://www.fda.gov/AdvisoryCommittees/default.htm
`45. http://www.fda.gov/ScienceResearch/default.htm
`46. http://www.fda.gov/RegulatoryInformation/default.htm
`47. http://www.fda.gov/Safety/default.htm
`48. http://www.fda.gov/EmergencyPreparedness/default.htm
`49. http://www.fda.gov/InternationalPrograms/default.htm
`50. http://www.fda.gov/NewsEvents/default.htm
`51. http://www.fda.gov/Training/default.htm
`52. http://www.fda.gov/ICECI/default.htm
`53. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`54. http://www.fda.gov/ForConsumers/default.htm
`55. http://www.fda.gov/ForIndustry/default.htm
`56. http://www.fda.gov/ForHealthProfessionals/default.htm
`57. http://www.accessdata.fda.gov/scripts/search/index.cfm?action=archive.search
`58. http://www.hhs.gov
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players22
`Accessibility23 Contact FDA24 Careers25 FDA Basics26 FOIA27 No Fear Act28 Site Map29 Transparency30 Website
`Policies31
`
`32
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1888INFOFDA (18884636332)
`Contact FDA33
`
`34
`
`35
`
`36
`
`37
`
`38
`
`39
`
`40
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`3/5
`
`Page 11 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`For Government41 For Press42
`Combination Products43 Advisory Committees44 Science & Research45 Regulatory Information46 Safety47 Emergency
`Preparedness48 International Programs49 News & Events50 Training and Continuing Education51
`Inspections/Compliance52 State & Local Officials53 Consumers54 Industry55 Health Professionals56 FDA Archive57
`
`58
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/UCM079874
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079846.htm
`11. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
`12. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
`13. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf
`14. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf
`15. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf
`16. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf
`17. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf
`18. http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf
`19. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf
`20. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`21. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm#web
`22. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/ViewingFiles/default.htm
`23. http://www.fda.gov/AboutFDA/AboutThisWebsite/Accessibility/default.htm
`24. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`25. http://www.fda.gov/AboutFDA/WorkingatFDA/default.htm
`26. http://www.fda.gov/AboutFDA/Transparency/Basics/default.htm
`27. http://www.fda.gov/RegulatoryInformation/FOI/default.htm
`28. http://www.fda.gov/AboutFDA/WorkingatFDA/NoFearAct/default.htm
`29. http://www.fda.gov/SiteMap/default.htm
`30. http://www.fda.gov/AboutFDA/Transparency/default.htm
`31. http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/default.htm
`32. http://www.fda.gov
`33. http://www.fda.gov/AboutFDA/ContactFDA/default.htm
`34. http://www.usa.gov
`35. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/GetEmailUpdates/default.htm
`36. http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm
`37. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#micro
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`4/5
`
`Page 12 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`38. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#Facebook
`39. http://www.fda.gov/NewsEvents/InteractiveMedia/ucm200145.htm
`40. http://www.fda.gov/NewsEvents/InteractiveMedia/default.htm#flickr
`41. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`42. http://www.fda.gov/NewsEvents/default.htm
`43. http://www.fda.gov/CombinationProducts/default.htm
`44. http://www.fda.gov/AdvisoryCommittees/default.htm
`45. http://www.fda.gov/ScienceResearch/default.htm
`46. http://www.fda.gov/RegulatoryInformation/default.htm
`47. http://www.fda.gov/Safety/default.htm
`48. http://www.fda.gov/EmergencyPreparedness/default.htm
`49. http://www.fda.gov/InternationalPrograms/default.htm
`50. http://www.fda.gov/NewsEvents/default.htm
`51. http://www.fda.gov/Training/default.htm
`52. http://www.fda.gov/ICECI/default.htm
`53. http://www.fda.gov/ForFederalStateandLocalOfficials/default.htm
`54. http://www.fda.gov/ForConsumers/default.htm
`55. http://www.fda.gov/ForIndustry/default.htm
`56. http://www.fda.gov/ForHealthProfessionals/default.htm
`57. http://www.accessdata.fda.gov/scripts/search/index.cfm?action=archive.search
`58. http://www.hhs.gov
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
`
`5/5
`
`Page 13 of 77
`
`

`
`2/14/2016
`
`Drugs@FDA: FDA Approved Drug Products
`
`FDA Home3 Drug Databases4 Drugs@FDA5
`
`
`
`
`
`Label and Approval History
`
`ACTOS
`Drug Name(s)
`FDA Application No. (NDA) 021073
`Active Ingredient(s) PIOGLITAZONE HYDROCHLORIDE
`Company
`TAKEDA PHARMS USA
`
`FAQ6  |  Instructions7  |   Glossary8  |   Contact Us9
`
`Email Link
`
`Label Information
`
`Go to Approval History
`
`What information does a label include?10
`Note: Not all labels are available in electronic format from FDA.
`View the label approved on 11/12/2013 (PDF)11 for NDA no. 021073
`To see older, previouslyapproved labels, go to the "Approval History" section of this page. Older labels
`are for historical information only and should not be used for clinical purposes.
`Approval History
`NDA 021073
`
`Note: Not all reviews are available in electronic format from FDA.
`Older labels are for historical information only, and should not be used for clinical purposes.
`Approval dates can only be verified from 1984 to the present.
`
`Click on a column header to resort the table:
`
`Action
`Date
`
`SupplementApproval
`
`Number
`Type
`
`11/12/2013 046
`
`Labeling Revision
`
`06/27/2013 047
`
`Manufacturing Change or Addition
`
`05/17/2012 045
`
`Labeling Revision
`
`08/04/2011 044
`
`Labeling Revision
`
`08/04/2011 043
`
`Labeling Revision
`
`02/03/2011 035
`07/29/2010 040
`
`Labeling Revision
`Labeling Revision
`
`09/09/2009 037
`
`Labeling Revision
`
`12/11/2008 034
`
`Labeling Revision
`
`05/07/2008 033
`
`Labeling Revision
`
`09/06/2007 030
`
`Labeling Revision
`
`08/14/2007 031
`
`Labeling Revision
`
`02/25/2007 026
`
`Efficacy Supplement with Clinical Data
`to Support
`
`Letters,
`Reviews,
`Labels,
`Patient Package Insert
`
`Label (PDF)12
`Letter (PDF)13
`
`
`Letter (PDF)14
`
`Label (PDF)15
`Letter (PDF)16
`Label (PDF)17
`Letter (PDF)18
`Label (PDF)19
`Letter (PDF)20
`
`Label (PDF)21
`Letter (PD

This document is available on Docket Alarm but you must sign up to view it.

Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

Up-to-date information for this case.
Email alerts whenever there is an update.
Full text search for other cases.
Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.

Access Government Site

We are redirecting you
to a mobile optimized page.

Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket

Supplemental Search

Search for PTAB Motions

PTAB Analytics

TTAB Analytics

Basic Search

Filters

Party Search

Advanced

Selected Courts

Recently Selected Courts

Find PTAB Decisions

PTAB Analytics

Special PTAB Alerts

Orange Book

Directly Search Federal Courts

Search Trademark ...

This document is available on Docket Alarm but you must sign up to view it.

Accessing this document will incur an additional charge of $.

Still Working On It

A few More Minutes ... Still Working

This document could not be displayed.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

One Moment Please

Your document is on its way!

Sealed Document

We are redirecting youto a mobile optimized page.

Document Unreadable or Corrupt

We are unable to display this document.

STEP 2 of 2

Choose your membership type

Flat-Fee

Pay-As-You-Go

Add your payment information

Login or Join

Enter your corporate Email

Thousands of your peers are saving time and gaining a competitive advantage with Docket Alarm.

Join Docket Alarm to perform smarter legal research.

Download this document and millions of others instantly with a Docket Alarm membership.

Join Docket Alarm and start performing smarter legal research.

Start tracking this docket instantly with a Docket Alarm membership.

Join thousands of your peers and start performing smarter legal research.

STEP 1 of 2

Millions of Documents | 15 Seconds to Signup

Hi !

Welcome to Docket Alarm

Welcome to Docket Alarm!

Explore Litigation Insights andManage Your Cases

Reset Password

What is PACER?

Why do I need it?

What will I be charged?

Do other courts have fees?

Basic Free Access

Welcome

Thank you

Check Firm Account

We are redirecting you
to a mobile optimized page.

Explore Litigation Insights and
Manage Your Cases