`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 202270
`Company: MSD SUB MERCK
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=202270)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf#page=34)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf)
`
`Products on NDA 202270
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`JANUMET XR
`
`JANUMET XR
`
`JANUMET XR
`
`METFORMIN HYDROCHLORIDE; SITAGLIPTIN
`PHOSPHATE
`
`METFORMIN HYDROCHLORIDE; SITAGLIPTIN
`PHOSPHATE
`
`METFORMIN HYDROCHLORIDE; SITAGLIPTIN
`PHOSPHATE
`
`Showing 1 to 3 of 3 entries
`
`500MG;EQ 50MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Prescription
`
`1GM;EQ 50MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Prescription
`
`1GM;EQ 100MG BASE
`
`TABLET, EXTENDED RELEASE;ORAL
`
`Prescription
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202270
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`02/02/2012
`
`ORIG-1
`
`Approval
`
`Type 3 - New
`Dosage Form
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270_janumet_xr_toc.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`06/21/2022
`
`SUPPL-26
`
`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/2022/202270s026lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf)
`
`11/04/2021
`
`SUPPL-25
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202270Orig1s025ltr.pdf)
`
`12/04/2020
`
`SUPPL-22
`
`08/12/2019
`
`SUPPL-19
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021995Orig1s047; 022044Orig1s048; 202270Orig1s022ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf)
`
`07/01/2019
`
`SUPPL-20
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf)
`
`Novo Nordisk Exhibit 2402
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`02/09/2018
`
`SUPPL-18
`
`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/2018/202270s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf)
`
`08/10/2017
`
`SUPPL-17
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf)
`
`01/18/2017
`
`SUPPL-16
`
`Labeling-Package
`Insert, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf)
`
`01/18/2017
`
`SUPPL-15
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202270Orig1s015,s016ltr.pdf)
`
`08/28/2015
`
`SUPPL-10
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf)
`
`04/27/2015
`
`SUPPL-9
`
`09/19/2014
`
`SUPPL-8
`
`02/12/2014
`
`SUPPL-6
`
`10/17/2013
`
`SUPPL-5
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf)
`
`Manufacturing
`(CMC)
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202270Orig1s006ltr.pdf)
`
`Manufacturing
`(CMC)
`
`07/19/2013
`
`SUPPL-4
`
`Manufacturing
`(CMC)
`
`04/10/2013
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`02/11/2013
`
`SUPPL-3
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202270Orig1s003ltr.pdf)
`
`10/18/2012
`
`SUPPL-2
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202270Orig1s002ltr.pdf)
`
`Showing 1 to 18 of 18 entries
`
`Labels for NDA 202270
`
`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 2402
`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): 202270
`Company: MSD SUB MERCK
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=202270)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf#page=34)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202270Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 202270
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 202270
`
`Labels for NDA 202270
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`06/21/2022
`
`SUPPL-26
`
`11/04/2021
`
`SUPPL-25
`
`12/04/2020
`
`SUPPL-22
`
`08/12/2019
`
`SUPPL-19
`
`07/01/2019
`
`SUPPL-20
`
`02/09/2018
`
`SUPPL-18
`
`08/10/2017
`
`SUPPL-17
`
`01/18/2017
`
`SUPPL-16
`
`01/18/2017
`
`SUPPL-16
`
`01/18/2017
`
`SUPPL-15
`
`08/28/2015
`
`SUPPL-10
`
`04/27/2015
`
`SUPPL-9
`
`02/12/2014
`
`SUPPL-6
`
`02/11/2013
`
`SUPPL-3
`
`02/11/2013
`
`SUPPL-3
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Medication
`Guide
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Medication
`Guide
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202270s026lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202270s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202270Orig1s022lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s019lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202270s020lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202270s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s017lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202270s015s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s010lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202270s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202270s006lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202270s003lbl.pdf)
`
`Novo Nordisk Exhibit 2402
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Action Date
`
`Submission
`
`10/18/2012
`
`SUPPL-2
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Medication
`Guide
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s002lbl.pdf)
`
`02/02/2012
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202270s000lbl.pdf)
`
`Showing 1 to 17 of 17 entries
`
`Novo Nordisk Exhibit 2402
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`