`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 204353
`Company: JANSSEN PHARMS
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204353)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf#page=56)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf)
`
`Products on NDA 204353
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`INVOKAMET
`
`INVOKAMET
`
`INVOKAMET
`
`INVOKAMET
`
`CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`50MG;500MG
`
`TABLET;ORAL
`
`CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`50MG;1GM
`
`TABLET;ORAL
`
`CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`150MG;500MG
`
`TABLET;ORAL
`
`CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
`
`150MG;1GM
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`Yes
`
`Showing 1 to 4 of 4 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204353
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`08/08/2014
`
`ORIG-1
`
`Approval
`
`Type 4 - New
`Combination
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204353Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/05/2023
`
`SUPPL-42
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204353Orig1s042;205879Orig1s019ltr.pdf)
`
`10/13/2022
`
`SUPPL-41
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204042Orig1s039,204353Orig1s041,205879Orig1s018ltr.pdf)
`
`08/18/2020
`
`SUPPL-39
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204353Orig1s039,205879Orig1s017ltr.pdf)
`
`01/27/2020
`
`SUPPL-33
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204353Orig1s033, 205879Orig1s011ltr.pdf)
`
`01/24/2020
`
`SUPPL-36
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s036,205879s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204042Orig1s036, 204353Orig1s036, 205879Orig1s014ltr.pdf)
`
`Novo Nordisk Exhibit 2443
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`10/29/2018
`
`SUPPL-25
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`E cacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204353Orig1s025,205879Orig1s007ltr.pdf)
`
`10/26/2018
`
`SUPPL-31
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s031lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204353Orig1s031,205879Orig1s009ltr.pdf)
`
`08/11/2017
`
`SUPPL-24
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s024ltr.pdf)
`
`07/25/2017
`
`SUPPL-23
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s023ltr.pdf)
`
`02/01/2017
`
`SUPPL-14
`
`11/23/2016
`
`SUPPL-19
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204353Orig1s014ltr.pdf)
`
`08/17/2016
`
`SUPPL-20
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s020ltr.pdf)
`
`05/20/2016
`
`SUPPL-15
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf)
`
`05/20/2016
`
`SUPPL-6
`
`04/14/2016
`
`SUPPL-11
`
`E cacy-New
`Indication
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s006,s015ltr.pdf)
`
`03/28/2016
`
`SUPPL-10
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204353Orig1s010ltr.pdf)
`
`03/17/2016
`
`SUPPL-8
`
`Manufacturing
`(CMC)
`
`12/23/2015
`
`SUPPL-7
`
`Manufacturing
`(CMC)
`
`12/04/2015
`
`SUPPL-12
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s012ltr.pdf)
`
`09/10/2015
`
`SUPPL-3
`
`06/08/2015
`
`SUPPL-4
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s003ltr.pdf)
`
`03/03/2015
`
`SUPPL-2
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204353Orig1s002ltr.pdf)
`
`Showing 1 to 22 of 22 entries
`
`Labels for NDA 204353
`
`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 2443
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`
`
`
`
`
`
`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): 204353
`Company: JANSSEN PHARMS
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204353)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf#page=56)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204353Orig1s000SumR.pdf)
`
`Products on NDA 204353
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204353
`
`Labels for NDA 204353
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/05/2023
`
`SUPPL-42
`
`10/13/2022
`
`SUPPL-41
`
`08/18/2020
`
`SUPPL-39
`
`01/27/2020
`
`SUPPL-33
`
`01/24/2020
`
`SUPPL-36
`
`10/29/2018
`
`SUPPL-25
`
`10/26/2018
`
`SUPPL-31
`
`08/11/2017
`
`SUPPL-24
`
`07/25/2017
`
`SUPPL-23
`
`02/01/2017
`
`SUPPL-14
`
`08/17/2016
`
`SUPPL-20
`
`05/20/2016
`
`SUPPL-15
`
`05/20/2016
`
`SUPPL-6
`
`03/28/2016
`
`SUPPL-10
`
`12/04/2015
`
`SUPPL-12
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-New
`Indication
`
`Labeling-Package
`Insert
`
`Labeling-
`Medication Guide
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204353s042,205879s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204353s041,205879s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s039,205879s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s033,205879s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204353s036,205879s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s025,205879s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204353s031lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s024lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204353s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s006s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204353s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s012lbl.pdf)
`
`Novo Nordisk Exhibit 2443
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`09/10/2015
`
`SUPPL-3
`
`03/03/2015
`
`SUPPL-2
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204353s002lbl.pdf)
`
`08/08/2014
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204353s000lbl.pdf)
`
`Showing 1 to 18 of 18 entries
`
`Novo Nordisk Exhibit 2443
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`