`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 204410
`Company: ACTELION PHARMS LTD
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204410)
`
`Medication Guide
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf#page=18)
`
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
`event=IndvRemsDetails.page&REMS=76)
`
`Products on NDA 204410
`
`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`MACITENTAN
`OPSUMIT
`Showing 1 to 1 of 1 entries
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`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`10MG
`
`TABLET;ORAL
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204410
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1091, p. 1 of 3
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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
`
`10/18/2013 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
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`STANDARD
`;
`Orphan
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204410s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204410Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204410Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`03/21/2017 SUPPL11
`
`Submission
`Classification
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Labeling
`Medication
`Guide, Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204410s011lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204410Orig1s011ltr.pdf)
`
`10/21/2016 SUPPL9
`
`Labeling
`Package Insert
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s009ltr.pdf)
`
`06/15/2016 SUPPL8
`
`Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s008ltr.pdf)
`
`03/22/2016 SUPPL5
`
`Manufacturing
`(CMC)
`
`02/22/2016 SUPPL7
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s007ltr.pdf)
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
`
`02/17/2016 SUPPL6
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`11/17/2015
`
`SUPPL2
`
`REMSModified
`
`04/30/2015 SUPPL3
`
`Labeling
`Package Insert
`
`05/20/2014 SUPPL1
`
`Manufacturing
`(CMC)
`
`Showing 1 to 9 of 9 entries
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`Labels for NDA 204410
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204410s006lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204410Orig1s006ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s002ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204410s003lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204410Orig1s003ltr.pdf)
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`WATSON LABORATORIES, INC. , IPR2017-01622, Ex. 1091, p. 3 of 3
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