`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 021995
`Company: MERCK SHARP DOHME
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021995)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf#page=27)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm)
`
`Products on NDA 021995
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`RLD
`
`JANUVIA
`
`JANUVIA
`
`JANUVIA
`
`SITAGLIPTIN PHOSPHATE
`
`EQ 25MG BASE
`
`SITAGLIPTIN PHOSPHATE
`
`EQ 50MG BASE
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`SITAGLIPTIN PHOSPHATE
`
`EQ 100MG BASE
`
`TABLET;ORAL
`
`Prescription
`
`Prescription
`
`Prescription
`
`None
`
`None
`
`None
`
`Yes
`
`Yes
`
`Yes
`
`Showing 1 to 3 of 3 entries
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021995
`
`RS
`
`No
`
`No
`
`Yes
`
`
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`10/16/2006
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`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/2006/021995lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021995s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021995s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`06/21/2022
`
`SUPPL-50
`
`12/04/2020
`
`SUPPL-47
`
`08/12/2019
`
`SUPPL-45
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-
`Medication Guide,
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021995Orig1s050, 022044Orig1s052, 202270Orig1s026ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.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/2019/021995s045lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s045, 202270Orig1s019, 022044Orig1s046.ltr.pdf)
`
`07/01/2019
`
`SUPPL-46
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021995Orig1s046, 022044Orig1s047, 202270Orig1s020ltr.pdf)
`
`02/09/2018
`
`SUPPL-42
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021995Orig1s042,022044s043,202270Orig1s018ltr.pdf)
`
`Novo Nordisk Exhibit 2399
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`Action
`Date
`
`Submission
`
`08/10/2017
`
`SUPPL-40
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s040,022044Orig1s042,202270Orig1s017ltr.pdf)
`
`01/18/2017
`
`SUPPL-38
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021995Orig1s038ltr.pdf)
`
`01/11/2016
`
`SUPPL-35
`
`Manufacturing
`(CMC)
`
`08/28/2015
`
`SUPPL-34
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s034,022044Orig1s035,202270Orig1s010ltr.pdf)
`
`04/27/2015
`
`SUPPL-33
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s033,022044Orig1s034,202270Orig1s009ltr.pdf)
`
`03/10/2015
`
`SUPPL-32
`
`10/17/2013
`
`SUPPL-28
`
`Manufacturing
`(CMC)
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021995Orig1s032ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf)
`
`08/19/2013
`
`SUPPL-29
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s029ltr.pdf)
`
`02/11/2013
`
`SUPPL-27
`
`12/07/2012
`
`SUPPL-26
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Medication Guide
`
`Manufacturing
`(CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021995Orig1s027ltr_replacement.pdf)
`
`10/18/2012
`
`SUPPL-25
`
`Labeling-
`Medication Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995Orig1s025ltr.pdf)
`
`03/24/2012
`
`SUPPL-23
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021995s023ltr.pdf)
`
`02/27/2012
`
`SUPPL-19
`
`06/10/2011
`
`SUPPL-16
`
`Labeling-Package
`Insert
`
`Labeling-
`Container/Carton
`Labels
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf)
`
`04/14/2011
`
`SUPPL-17
`
`Labeling, REMS-
`Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021995s017ltr.pdf)
`
`09/24/2010
`
`SUPPL-18
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf)
`
`09/24/2010
`
`SUPPL-15
`
`02/26/2010
`
`SUPPL-14
`
`02/26/2010
`
`SUPPL-12
`
`02/26/2010
`
`SUPPL-11
`
`02/26/2010
`
`SUPPL-10
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s015,s018ltr.pdf)
`
`Labeling-
`Medication Guide,
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021995Orig1s014.pdf)
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021995s010s011s012s014ltr.pdf)
`
`Novo Nordisk Exhibit 2399
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories or
`Approval Type
`
`12/28/2009
`
`SUPPL-13
`
`Labeling
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021995s013ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021995Orig1s013.pdf)
`
`10/20/2008
`
`SUPPL-9
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s009ltr.pdf)
`
`07/22/2008
`
`SUPPL-7
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021995s007ltr.pdf)
`
`10/12/2007
`
`SUPPL-6
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf)
`
`10/12/2007
`
`SUPPL-4
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf)
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021995s002, s003, s004, s006ltr.pdf)
`
`10/12/2007
`
`SUPPL-3
`
`10/12/2007
`
`SUPPL-2
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`E cacy-Labeling
`Change With
`Clinical Data
`
`04/10/2007
`
`SUPPL-1
`
`Manufacturing
`(CMC)-Control
`
`Showing 1 to 34 of 34 entries
`
`Labels for NDA 021995
`
`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.
`
`Label is
`not
`available
`on this
`site.
`
`
`
`Novo Nordisk Exhibit 2399
`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): 021995
`Company: MERCK SHARP DOHME
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=021995)
`Medication Guide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf#page=27)
`Other Important Information from FDA (http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm)
`
`Products on NDA 021995
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 021995
`
`Labels for NDA 021995
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`06/21/2022
`
`SUPPL-50
`
`06/21/2022
`
`SUPPL-50
`
`12/04/2020
`
`SUPPL-47
`
`08/12/2019
`
`SUPPL-45
`
`07/01/2019
`
`SUPPL-46
`
`02/09/2018
`
`SUPPL-42
`
`08/10/2017
`
`SUPPL-40
`
`01/18/2017
`
`SUPPL-38
`
`08/28/2015
`
`SUPPL-34
`
`04/27/2015
`
`SUPPL-33
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Medication
`Guide
`
`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-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021995s050lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021995s047lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s045lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021995s046lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021995s042lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s040lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021995s038lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s034lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s033lbl.pdf)
`
`03/10/2015
`
`SUPPL-32
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021995s032lbl.pdf)
`
`10/17/2013
`
`SUPPL-28
`
`Manufacturing (CMC)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s028lbl.pdf)
`
`08/19/2013
`
`SUPPL-29
`
`Labeling-Medication
`Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s029lbl.pdf)
`
`
`
`
`
`
`
`Note
`
`This
`supplement
`type does not
`usually require
`new labeling.
`
`This
`supplement
`type does not
`usually require
`new labeling.
`
`Novo Nordisk Exhibit 2399
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Action Date
`
`Submission
`
`02/11/2013
`
`SUPPL-27
`
`02/11/2013
`
`SUPPL-27
`
`10/18/2012
`
`SUPPL-25
`
`03/24/2012
`
`SUPPL-23
`
`02/27/2012
`
`SUPPL-19
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-Medication
`Guide
`
`Labeling-Medication
`Guide
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Note
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021995s027lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s025lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021995s019lbl.pdf)
`
`04/14/2011
`
`SUPPL-17
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf)
`
`04/14/2011
`
`SUPPL-17
`
`REMS-Modi ed
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021995s017lbl.pdf)
`
`09/24/2010
`
`SUPPL-18
`
`09/24/2010
`
`SUPPL-15
`
`02/26/2010
`
`SUPPL-14
`
`Labeling-Package
`Insert
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Labeling-Medication
`Guide
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s015s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`
`02/26/2010
`
`SUPPL-14
`
`REMS-Proposal
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`
`02/26/2010
`
`SUPPL-12
`
`02/26/2010
`
`SUPPL-11
`
`02/26/2010
`
`SUPPL-10
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`12/28/2009
`
`SUPPL-13
`
`07/22/2008
`
`SUPPL-7
`
`10/16/2006
`
`ORIG-1
`
`Labeling
`
`Labeling
`
`Approval
`
`Showing 1 to 30 of 30 entries
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021995s010s011s012s014lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021995s013lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021995s007lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021995lbl.pdf)
`
`Novo Nordisk Exhibit 2399
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`