`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020357
`Company: EMD SERONO INC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020357)
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`
`Products on NDA 020357
`
`CSV
`
`Excel
`
`
`Drug Name
`
`Active Ingredients
`
`Strength
`
`Dosage Form/Route
`
`Marketing Status
`
`TE Code
`
`GLUCOPHAGE
`
`METFORMIN HYDROCHLORIDE
`
`GLUCOPHAGE
`
`METFORMIN HYDROCHLORIDE
`
`GLUCOPHAGE
`
`METFORMIN HYDROCHLORIDE
`
`GLUCOPHAGE
`
`METFORMIN HYDROCHLORIDE
`
`GLUCOPHAGE
`
`METFORMIN HYDROCHLORIDE
`
`Showing 1 to 5 of 5 entries
`
`500MG **Federal Register determination
`that product was not discontinued or
`withdrawn for safety or effectiveness
`reasons**
`
`850MG **Federal Register determination
`that product was not discontinued or
`withdrawn for safety or effectiveness
`reasons**
`
`625MG **Federal Register determination
`that product was not discontinued or
`withdrawn for safety or effectiveness
`reasons**
`
`750MG **Federal Register determination
`that product was not discontinued or
`withdrawn for safety or effectiveness
`reasons**
`
`1GM **Federal Register determination that
`product was not discontinued or withdrawn
`for safety or effectiveness reasons**
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`TABLET;ORAL
`
`Discontinued
`
`None
`
`RLD
`
`Yes
`
`RS
`
`No
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`No
`
`No
`
`No
`
`No
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020357
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`03/03/1995
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classi cation
`
`Type 1 - New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`PRIORITY
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020357Orig1s000rev.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`05/30/2018
`
`SUPPL-34
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020357Orig1s034, 021202Orig1s018ltr.pdf)
`
`Notes
`
`Label is
`not
`available
`on this
`site.
`
`Note
`
`Novo Nordisk Exhibit 2369
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00001
`
`
`
`Action
`Date
`
`Submission
`
`04/05/2017
`
`SUPPL-39
`
`Supplement
`Categories or
`Approval Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf)
`
`04/05/2017
`
`SUPPL-37
`
`Labeling-Package
`Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020357Orig1s037s039,021202Orig1s021s023ltr.pdf)
`
`11/13/2013
`
`SUPPL-36
`
`Manufacturing
`(CMC)
`
`03/14/2013
`
`SUPPL-35
`
`Manufacturing
`(CMC)
`
`08/27/2008
`
`SUPPL-31
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020357s031, 021202s016ltr.pdf)
`
`11/01/2006
`
`SUPPL-30
`
`Labeling
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020357s030,021202s015ltr.pdf)
`
`03/19/2004
`
`SUPPL-27
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf)
`
`03/19/2004
`
`SUPPL-26
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20357slr026,027,21202slr011,013ltr.pdf)
`
`01/08/2002
`
`SUPPL-24
`
`Labeling
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21202s3ltr.pdf)
`
`04/19/2001
`
`SUPPL-20
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20357S20ltr.pdf)
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020357_S020_GLUCOPHAGE_AP.pdf)
`
`02/08/2001
`
`SUPPL-22
`
`Labeling
`
`12/15/2000
`
`SUPPL-19
`
`E cacy-New Patient
`Population
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20357S19LTR.PDF)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357s19_glucophage.cfm)
`
`08/04/2000
`
`SUPPL-21
`
`Manufacturing
`(CMC)
`
`09/22/1999
`
`SUPPL-17
`
`E cacy-Labeling
`Change With Clinical
`Data
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20357S17.PDF)
`
`06/07/1999
`
`SUPPL-18
`
`Manufacturing
`(CMC)-Control
`
`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.
`
`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 2369
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00002
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`06/01/1999
`
`SUPPL-15
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing
`(CMC)
`
`03/12/1999
`
`SUPPL-16
`
`Manufacturing
`(CMC)
`
`12/04/1998
`
`SUPPL-14
`
`Manufacturing
`(CMC)-Control
`
`11/18/1998
`
`SUPPL-13
`
`Manufacturing
`(CMC)
`
`11/05/1998
`
`SUPPL-11
`
`Manufacturing
`(CMC)-Formulation
`
`10/22/1998
`
`SUPPL-10
`
`E cacy-New
`Indication
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20357s10ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020357s010.cfm)
`
`07/02/1998
`
`SUPPL-9
`
`Manufacturing
`(CMC)
`
`05/15/1998
`
`SUPPL-7
`
`Manufacturing
`(CMC)
`
`02/10/1998
`
`SUPPL-8
`
`Labeling
`
`11/06/1997
`
`SUPPL-6
`
`Labeling
`
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020357a_s006.pdf)
`
`06/06/1997
`
`SUPPL-5
`
`Manufacturing
`(CMC)
`
`07/26/1996
`
`SUPPL-4
`
`Manufacturing
`(CMC)
`
`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.
`
`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 2369
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00003
`
`
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`04/30/1996
`
`SUPPL-3
`
`Supplement
`Categories or
`Approval Type
`
`Manufacturing
`(CMC)-Control
`
`09/13/1995
`
`SUPPL-2
`
`Manufacturing
`(CMC)-Packaging
`
`Showing 1 to 30 of 30 entries
`
`Labels for NDA 020357
`
`Note
`
`Label is
`not
`available
`on this
`site.
`
`Label is
`not
`available
`on this
`site.
`
`
`
`Novo Nordisk Exhibit 2369
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00004
`
`
`
`Drug Databases (https://www.fda.gov/Drugs/InformationOnDrugs/default.htm)
`
`Drugs@FDA: FDA-Approved Drugs
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 020357
`Company: EMD SERONO INC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=020357)
`
`Products on NDA 020357
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 020357
`
`Labels for NDA 020357
`
`CSV
`
`Excel
`
`
`Action Date
`
`Submission
`
`05/30/2018
`
`SUPPL-34
`
`04/05/2017
`
`SUPPL-39
`
`04/05/2017
`
`SUPPL-37
`
`08/27/2008
`
`SUPPL-31
`
`11/01/2006
`
`SUPPL-30
`
`12/15/2000
`
`SUPPL-19
`
`Showing 1 to 6 of 6 entries
`
`Supplement
`Categories or
`Approval Type
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling-Package
`Insert
`
`Labeling
`
`Labeling
`
`E cacy-New
`Patient Population
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020357s034,021202s018lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020357s037s039,021202s021s023lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020357s030,021202s015lbl.pdf)
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20357S019_Glucophage_prntlbl.pdf)
`
`
`
`
`
`
`
`Note
`
`Novo Nordisk Exhibit 2369
`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00005
`
`