5/17/2017
`
`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=BASICSEARCH.PROCESS)
`
` 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=BASICSEARCH.PROCESS)
`
`
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022081
`Company: GILEAD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022081)
`
`Medication Guide (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf)
`
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
`event=IndvRemsDetails.page&REMS=28)
`
`Products on NDA 022081
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`LETAIRIS
`
`AMBRISENTAN
`
`AMBRISENTAN
`LETAIRIS
`Showing 1 to 2 of 2 entries
`
`Strength
`
`5MG
`
`10MG
`
`Dosage
`Form/Route
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Marketing
`Status
`
`Prescription
`
`Prescription
`
`TE
`Code
`
`None
`
`None
`
`RLD
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022081
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`
`
`
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`1/5
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`
`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=BASICSEARCH.PROCESS)
`
` 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=BASICSEARCH.PROCESS)
`
`
`
`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
`
`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 022081
`Company: GILEAD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=022081)
`
`Medication Guide (http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088617.pdf)
`
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
`event=IndvRemsDetails.page&REMS=28)
`
`Products on NDA 022081
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`LETAIRIS
`
`AMBRISENTAN
`
`AMBRISENTAN
`LETAIRIS
`Showing 1 to 2 of 2 entries
`
`Strength
`
`5MG
`
`10MG
`
`Dosage
`Form/Route
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Marketing
`Status
`
`Prescription
`
`Prescription
`
`TE
`Code
`
`None
`
`None
`
`RLD
`
`Yes
`
`Yes
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022081
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`
`
`
`
`1/5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1090, p. 1 of 5
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`06/15/2007 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`PRIORITY
`;
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022081s000_LBL.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s000LTR.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022081s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`12/15/2016 SUPPL36
`
`Submission
`Classification
`
`REMS
`MODIFIED D
`NA
`
`03/21/2016 SUPPL35
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022081Orig1s036ltr.pdf)
`
`10/02/2015 SUPPL33
`
`EfficacyNew
`Indication
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022081s033lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022081Orig1s033ltr.pdf)
`
`09/25/2015 SUPPL34
`
`Manufacturing
`(CMC)
`
`10/29/2014 SUPPL32
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s032ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`2/5
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`
`
`5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s029lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s029ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022081s030lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022081Orig1s030ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022081s019lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022081Orig1s019ltr.pdf)
`
`Action
`Date
`
`Submission
`
`09/26/2014 SUPPL28
`
`Submission
`Classification
`
`Manufacturing
`(CMC)
`
`07/02/2014 SUPPL26
`
`Manufacturing
`(CMC)
`
`05/05/2014 SUPPL29
`
`Labeling
`Package Insert
`
`01/31/2014 SUPPL30
`
`REMSModified
`
`08/17/2013 SUPPL19
`
`01/16/2013 SUPPL24
`
`REMS
`Modified,
`REMS
`Assessment
`
`Manufacturing
`(CMC)
`
`01/10/2013 SUPPL23
`
`Manufacturing
`(CMC)
`
`10/19/2012 SUPPL22
`
`Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s022lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081Orig1s022ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`3/5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1090, p. 3 of 5
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`
`
`5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`02/15/2012 SUPPL14
`
`Efficacy
`Labeling
`Change With
`Clinical Data,
`REMS
`Assessment
`
`07/19/2011
`
`SUPPL18
`
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022081s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022081s014ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s018lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s018ltr.pdf)
`
`03/03/2011
`
`SUPPL17
`
`10/13/2010 SUPPL12
`
`Labeling
`Package Insert,
`REMSModified
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022081s017lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022081s017ltr.pdf)
`Review (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022081Orig1s017.pdf)
`
`Labeling,
`REMS
`Assessment
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022081s012lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s012ltr.pdf)
`
`08/24/2010 SUPPL16
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022081s016ltr.pdf)
`
`08/05/2009 SUPPL10
`
`Labeling
`
`07/01/2009 SUPPL11
`
`05/29/2009 SUPPL8
`
`REMS
`Modified,
`Labeling
`
`REMS
`Proposal,
`Labeling
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s010lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s010ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s011lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s011ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022081s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022081s008ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`4/5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1090, p. 4 of 5
`
`
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`5/17/2017
`
`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`10/08/2008 SUPPL4
`
`Labeling
`
`02/14/2008 SUPPL2
`
`Labeling
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s004ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022081s002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022081s002ltr.pdf)
`
`11/29/2007
`
`SUPPL1
`
`Labeling
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022081s001ltr.pdf)
`
`Showing 1 to 24 of 24 entries
`
`Labels for NDA 022081
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
`
`5/5
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`WATSON LABORATORIES, INC. , IPR2017-01621, Ex. 1090, p. 5 of 5
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