`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`Home (index.cfm) | Previous Page
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`New Drug Application (NDA): 207947
`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=207947)
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`Products on NDA 207947
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`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`Strength
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`UPTRAVI
`
`SELEXIPAG
`
`0.2MG
`
`0.4MG
`
`0.6MG
`
`0.8MG
`
`1MG
`
`1.2MG
`
`1.4MG
`
`1.6MG
`
`Dosage
`Form/Route
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Marketing
`Status
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`TE
`Code
`
`RLD
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`None
`
`None
`
`None
`
`None
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`None
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`None
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`None
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`None
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`1/2
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`WATSON LABORATORIES, INC. , IPR2017-01621, Corrected Ex. 1097, p. 1 of 2
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
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`Showing 1 to 8 of 8 entries
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 207947
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`
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`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`12/21/2015 ORIG1
`
`Approval
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`Type 1 New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`;
`Orphan
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`Showing 1 to 1 of 1 entries
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`Labels for NDA 207947
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`Letters, Reviews, Labels, Patient Package Insert
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`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207947s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207947Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207947Orig1s000SumR.pdf)
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`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`2/2
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`WATSON LABORATORIES, INC. , IPR2017-01621, Corrected Ex. 1097, p. 2 of 2
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