`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug Products
`
` SHARE (HTTPS://WWW.FACEBOOK.COM/SHARER/SHARER.PHP?U=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS&APPLNO=019670)
`
` TWEET (HTTPS://TWITTER.COM/INTENT/TWEET/?TEXT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=019670)
`
` LINKEDIN (HTTPS://WWW.LINKEDIN.COM/SHAREARTICLE?MINI=TRUE&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=019670&TITLE=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&SOURCE=FDA)
`
` PIN IT (HTTPS://WWW.PINTEREST.COM/PIN/CREATE/BUTTON/?URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=019670&DESCRIPTION=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS)
`
`
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?
`EVENT=OVERVIEW.PROCESS&APPLNO=019670)
`
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 019670
`Company: BAYER HEALTHCARE LLC
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=019670)
`
`Products on NDA 019670
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`
`
`1/7
`
`Exhibit 1109
`IPR2017-00807
`ARGENTUM
`
`000001
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`CSV
`
`Excel
`
`
`Drug
`Name
`
`Active
`Ingredients
`
`CLARITIN-
`D
`
`LORATADINE;
`PSEUDOEPHEDRINE
`SULFATE
`
`Showing 1 to 1 of 1 entries
`
`Strength
`
`5MG;120MG
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RS
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`Over-the-
`counter
`
`None
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 019670
`
`
`
`Original Approvals or Tentative Approvals
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`11/14/1994
`
`ORIG-1
`
`Action
`Type
`
`Approval
`
`Submission
`Classification
`
`Type 4 - New
`Combination
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`
`Letters,
`Reviews,
`Labels, Patient
`Package Insert
`
`Notes
`
`Label is not
`available on
`this site.
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`2/7
`
`000002
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`CSV
`
`Excel
`
`
`Action
`Date
`
`Submission
`
`11/25/2015
`
`SUPPL-32
`
`10/18/2013
`
`SUPPL-31
`
`Supplement
`Categories
`or Approval
`Type
`
`Labeling-
`Container/Carton
`Labels
`
`Manufacturing
`(CMC)
`
`03/13/2013
`
`SUPPL-30
`
`Manufacturing
`(CMC)
`
`01/25/2010
`
`SUPPL-22
`
`04/23/2009
`
`SUPPL-20
`
`Labeling-
`Container/Carton
`Labels
`
`Labeling-
`Container/Carton
`Labels, Labeling-
`Package Insert
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/applet
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/applet
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/applet
`Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`3/7
`
`000003
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`07/30/2004
`
`SUPPL-19
`
`Supplement
`Categories
`or Approval
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Efficacy-New
`Indication
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/applet
`
`11/27/2002
`
`SUPPL-18
`
`Efficacy-Rx To
`OTC Switch
`
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/applet
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/
`
`03/04/2002
`
`SUPPL-17
`
`Manufacturing
`(CMC)-Expiration
`Date
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/
`
`11/01/2000
`
`SUPPL-15
`
`Manufacturing
`(CMC)-Control
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/
`
`09/13/2000
`
`SUPPL-13
`
`Manufacturing
`(CMC)-Control
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`4/7
`
`000004
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`03/22/2000
`
`SUPPL-14
`
`Supplement
`Categories
`or Approval
`Type
`
`Manufacturing
`(CMC)-Control
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/
`
`01/27/1999
`
`SUPPL-9
`
`Manufacturing
`(CMC)-Control
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/
`
`10/29/1998
`
`SUPPL-12
`
`Manufacturing
`(CMC)
`
`Review
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_
`
`05/04/1998
`
`SUPPL-7
`
`Manufacturing
`(CMC)-Control
`
`04/29/1998
`
`SUPPL-10
`
`Labeling
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`5/7
`
`000005
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`01/23/1998
`
`SUPPL-8
`
`Supplement
`Categories
`or Approval
`Type
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Manufacturing
`(CMC)
`
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/
`DTOC.cfml)
`
`07/21/1997
`
`SUPPL-5
`
`Manufacturing
`(CMC)-Control
`
`07/14/1997
`
`SUPPL-6
`
`Labeling
`
`02/07/1997
`
`SUPPL-1
`
`Manufacturing
`(CMC)-Control
`
`02/05/1997
`
`SUPPL-4
`
`Labeling
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`6/7
`
`000006
`
`
`
`2/10/2018
`
`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Action
`Date
`
`Submission
`
`Supplement
`Categories
`or Approval
`Type
`
`04/29/1996
`
`SUPPL-3
`
`Labeling
`
`09/22/1995
`
`SUPPL-2
`
`Manufacturing
`(CMC)-Control
`
`Showing 1 to 22 of 22 entries
`
`Labels for NDA 019670
`
`Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route
`
`
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019670
`
`7/7
`
`000007
`
`