`
`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)
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`PRODUCTS&URL=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
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`EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTPS://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=BASICSEARCH.PROCESS)
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`Home (index.cfm) | Previous Page
`
`New Drug Application (NDA): 204819
`Company: BAYER HLTHCARE
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=204819)
`
`Medication Guide
`(http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf#page=24)
`
`REMS (http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?
`event=IndvRemsDetails.page&REMS=149)
`
`Products on NDA 204819
`
`CSVExcelPrint
`
`Drug Name
`
`Active
`Ingredients
`
`ADEMPAS
`
`RIOCIGUAT
`
`ADEMPAS
`
`RIOCIGUAT
`
`ADEMPAS
`
`RIOCIGUAT
`
`ADEMPAS
`
`RIOCIGUAT
`
`
`
`Strength
`
`0.5MG
`
`1MG
`
`1.5MG
`
`2MG
`
`Dosage
`Form/Route
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`TABLET;ORAL
`
`Marketing
`Status
`
`Prescription
`
`Prescription
`
`Prescription
`
`Prescription
`
`TE
`Code
`
`None
`
`None
`
`None
`
`None
`
`RLD
`
`Yes
`
`Yes
`
`Yes
`
`Yes
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
`
`Drug Name
`
`Active
`Ingredients
`
`Strength
`
`Dosage
`Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`RIOCIGUAT
`ADEMPAS
`Showing 1 to 5 of 5 entries
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`2.5MG
`
`TABLET;ORAL
`
`Prescription
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`Yes
`
`None
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`Approval Date(s) and History, Letters, Labels, Reviews for NDA 204819
`
`
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`10/08/2013 ORIG1
`
`Approval
`
`Type 1 New
`Molecular Entity
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`;
`Orphan
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`02/23/2017 SUPPL8
`
`01/17/2017 SUPPL6
`
`10/04/2016 SUPPL7
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`REMS
`MODIFIED D
`NA
`
`REMS
`MODIFIED D
`NA
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s008ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s006ltr.pdf)
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`5/17/2017
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`Drugs@FDA: FDA Approved Drug Products
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf)
`
`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`12/04/2015 SUPPL4
`
`REMSModified
`
`02/23/2015 SUPPL3
`
`Manufacturing
`(CMC)
`
`06/11/2014
`
`SUPPL1
`
`REMSModified
`
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf)
`
`05/06/2014 SUPPL2
`
`Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf)
`
`Showing 1 to 7 of 7 entries
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`Labels for NDA 204819
`
`
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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