`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020496
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020496)
`
`Products on NDA 020496
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`AMARYL
`
`AMARYL
`
`AMARYL
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`Showing 1 to 3 of 3 entries
`
`1MG
`
`2MG
`
`4MG
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`AB
`
`AB
`
`AB
`
`Yes
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020496
`
`RS
`
`Yes
`
`No
`
`No
`
`
`
`
`
`Notes
`
`Label is
`not
`available
`on this
`site.
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`STANDARD
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020496Orig1s000rev.pdf)
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`11/30/1995
`
`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
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`12/21/2018
`
`SUPPL-29
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020496Orig1s029Ltr.pdf)
`
`12/19/2016
`
`SUPPL-28
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020496Orig1s028ltr.pdf)
`
`10/15/2013
`
`SUPPL-27
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s027ltr.pdf)
`
`08/01/2013
`
`SUPPL-26
`
`Labeling-Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020496Orig1s026ltr.pdf)
`
`04/19/2013
`
`SUPPL-25
`
`Manufacturing (CMC)
`
`03/14/2013
`
`SUPPL-24
`
`Manufacturing (CMC)
`
`Label is not
`available on
`this site.
`
`Label is not
`available on
`this site.
`
`Novo Nordisk Exhibit 2365
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action Date
`
`Submission
`
`02/03/2012
`
`SUPPL-22
`
`06/04/2009
`
`SUPPL-21
`
`02/03/2009
`
`SUPPL-19
`
`02/03/2009
`
`SUPPL-18
`
`11/28/2005
`
`SUPPL-15
`
`09/19/2005
`
`SUPPL-16
`
`08/16/2004
`
`SUPPL-13
`
`Supplement
`Categories or
`Approval Type
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020496s022ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s021ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020496s018, s019ltr.pdf)
`
`E cacy-New Patient
`Population
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s015ltr.pdf)
`
`Labeling
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020496s016ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20496s013ltr.pdf)
`
`04/15/2002
`
`SUPPL-7
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20496s7ltr.pdf)
`
`07/21/2001
`
`SUPPL-11
`
`Manufacturing (CMC)
`
`12/05/2000
`
`SUPPL-10
`
`09/27/2000
`
`SUPPL-5
`
`08/29/2000
`
`SUPPL-9
`
`Manufacturing (CMC)-
`Control
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Manufacturing (CMC)-
`Control
`
`01/06/2000
`
`SUPPL-6
`
`Manufacturing (CMC)
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20496-S005_Amaryl.pdf)
`
`02/24/1999
`
`SUPPL-2
`
`E cacy-New Indication
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20496s2ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020496S002.cfm)
`
`09/16/1998
`
`SUPPL-4
`
`09/16/1998
`
`SUPPL-3
`
`Manufacturing (CMC)-
`Packaging
`
`Manufacturing (CMC)-
`Packaging
`
`07/28/1997
`
`SUPPL-1
`
`Manufacturing (CMC)
`
`Showing 1 to 23 of 23 entries
`
`Labels for NDA 020496
`
`Therapeutic Equivalents for NDA 020496
`
`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 2365
`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): 020496
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020496)
`
`Products on NDA 020496
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020496
`
`Labels for NDA 020496
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`12/21/2018
`
`SUPPL-29
`
`12/19/2016
`
`SUPPL-28
`
`10/15/2013
`
`SUPPL-27
`
`08/01/2013
`
`SUPPL-26
`
`02/03/2012
`
`SUPPL-22
`
`06/04/2009
`
`SUPPL-21
`
`02/03/2009
`
`SUPPL-19
`
`02/03/2009
`
`SUPPL-18
`
`11/28/2005
`
`SUPPL-15
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`Labeling
`
`Labeling
`
`E cacy-New Patient
`Population
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020496s029lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020496s028lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020496s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020496s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s021lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020496s018s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s015lbl.pdf)
`
`09/19/2005
`
`SUPPL-16
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020496s016lbl.pdf)
`
`Showing 1 to 10 of 10 entries
`
`Therapeutic Equivalents for NDA 020496
`
`
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2365
`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): 020496
`Company: SANOFI AVENTIS US
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020496)
`
`Products on NDA 020496
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020496
`
`Labels for NDA 020496
`
`Therapeutic Equivalents for NDA 020496
`
`AMARYL
`TABLET;ORAL; 1MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`
`
`
`
`
`
`
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`AMARYL
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`1MG
`
`1MG
`
`1MG
`
`1MG
`
`1MG
`
`1MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`020496
`
`078181 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078181)
`
`202759 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202759)
`
`077911 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077911)
`
`077295 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077295)
`
`SANOFI AVENTIS
`US
`
`ACCORD
`HLTHCARE
`
`AUROBINDO
`PHARMA LTD
`
`CARLSBAD
`
`CHARTWELL
`MOLECULAR
`
`DR REDDYS LABS
`LTD
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`1MG
`
`1MG
`
`1MG
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`077091 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077091)
`
`202112 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202112)
`
`091220 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=091220)
`
`077370 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077370)
`
`INDOCO
`REMEDIES
`
`MICRO LABS
`
`PRINSTON INC
`
`Showing 1 to 9 of 9 entries
`
`TABLET;ORAL; 2MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`AMARYL
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`2MG
`
`2MG
`
`2MG
`
`2MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`020496
`
`078181 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078181)
`
`202759 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202759)
`
`077911 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077911)
`
`SANOFI AVENTIS
`US
`
`ACCORD
`HLTHCARE
`
`AUROBINDO
`PHARMA LTD
`
`CARLSBAD
`
`Novo Nordisk Exhibit 2365
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`2MG
`
`2MG
`
`2MG
`
`2MG
`
`2MG
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`Showing 1 to 9 of 9 entries
`
`TABLET;ORAL; 4MG
`TE Code = AB
`
`CSV
`
`Excel
`
`
`Company
`
`CHARTWELL
`MOLECULAR
`
`077295 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077295)
`
`077091 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077091)
`
`DR REDDYS LABS
`LTD
`
`202112 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202112)
`
`091220 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=091220)
`
`077370 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077370)
`
`INDOCO
`REMEDIES
`
`MICRO LABS
`
`PRINSTON INC
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`RLD
`
`TE
`Code
`
`Application No.
`
`Company
`
`GLIMEPIRIDE
`
`4MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`AB
`
`020496
`
`AMARYL
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`GLIMEPIRIDE
`
`Showing 1 to 9 of 9 entries
`
`4MG
`
`4MG
`
`4MG
`
`4MG
`
`4MG
`
`4MG
`
`4MG
`
`4MG
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`TABLET;ORAL
`
`Prescription
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`No
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`AB
`
`078181 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=078181)
`
`202759 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202759)
`
`077911 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077911)
`
`077295 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077295)
`
`077091 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077091)
`
`202112 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=202112)
`
`091220 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=091220)
`
`077370 (/scripts/cder/daf/index.cfm?
`event=overview.process&ApplNo=077370)
`
`SANOFI AVENTIS
`US
`
`ACCORD
`HLTHCARE
`
`AUROBINDO
`PHARMA LTD
`
`CARLSBAD
`
`CHARTWELL
`MOLECULAR
`
`DR REDDYS LABS
`LTD
`
`INDOCO
`REMEDIES
`
`MICRO LABS
`
`PRINSTON INC
`
`Novo Nordisk Exhibit 2365
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`