`
`Drugs@FDA: FDA-Approved Drugs
`
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`New Drug Application (NDA): 022271
`Company: TAKEDA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022271)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf#page=28)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf)
`
`Products on NDA 022271
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`RS
`
`NESINA
`
`NESINA
`
`NESINA
`
`ALOGLIPTIN BENZOATE
`
`EQ 6.25MG BASE
`
`ALOGLIPTIN BENZOATE
`
`EQ 12.5MG BASE
`
`ALOGLIPTIN BENZOATE
`
`EQ 25MG BASE
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`Yes
`
`Showing 1 to 3 of 3 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022271
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classi cation
`
`01/25/2013
`
`ORIG-1
`
`Approval
`
`Type 1 - New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Notes
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022271Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`07/27/2023
`
`SUPPL-15
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022271Orig1s015;203414Orig1s016ltr.pdf)
`
`03/11/2022
`
`SUPPL-13
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022271Orig1s013; 022426Orig1s014; 203414Orig1s013ltr.pdf)
`
`07/01/2019
`
`SUPPL-12
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022271Orig1s012, 022426Orig1s012, 203414Orig1s012ltr.pdf)
`
`12/12/2016
`
`SUPPL-11
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s011ltr.pdf)
`
`05/27/2016
`
`SUPPL-9
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s009ltr.pdf)
`
`Novo Nordisk Exhibit 2427
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`04/19/2016
`
`SUPPL-8
`
`04/05/2016
`
`SUPPL-5
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing
`(CMC)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022271Orig1s005,022426Orig1s003,203414Orig1s003ltr.pdf)
`
`08/28/2015
`
`SUPPL-7
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022271Orig1s007,022426Orig1s005,203414Orig1s005ltr.pdf)
`
`07/20/2015
`
`SUPPL-6
`
`Manufacturing
`(CMC)
`
`08/15/2013
`
`SUPPL-3
`
`Manufacturing
`(CMC)
`
`06/26/2013
`
`SUPPL-2
`
`Manufacturing
`(CMC)
`
`05/30/2013
`
`SUPPL-1
`
`Manufacturing
`(CMC)
`
`Showing 1 to 12 of 12 entries
`
`Labels for NDA 022271
`
`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.
`
`
`
`Novo Nordisk Exhibit 2427
`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): 022271
`Company: TAKEDA PHARMS USA
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022271)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf#page=28)
`Summary Review (http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022271Orig1s000SumR.pdf)
`
`
`
`
`
`
`
`Note
`
`Products on NDA 022271
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022271
`
`Labels for NDA 022271
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`07/27/2023
`
`SUPPL-15
`
`03/11/2022
`
`SUPPL-13
`
`07/01/2019
`
`SUPPL-12
`
`12/12/2016
`
`SUPPL-11
`
`05/27/2016
`
`SUPPL-9
`
`04/05/2016
`
`SUPPL-5
`
`08/28/2015
`
`SUPPL-7
`
`Supplement
`Categories or
`Approval Type
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022271s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022271s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022271s012lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s011lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s009lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022271s005lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022271s007lbl.pdf)
`
`01/25/2013
`
`ORIG-1
`
`Approval
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022271s000lbl.pdf)
`
`Showing 1 to 8 of 8 entries
`
`Novo Nordisk Exhibit 2427
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`