Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET;ORAL | 0.5MG | 1 | ADEMPAS | RIOCIGUAT |
| 002 | TABLET;ORAL | 1MG | 1 | ADEMPAS | RIOCIGUAT |
| 003 | TABLET;ORAL | 1.5MG | 1 | ADEMPAS | RIOCIGUAT |
| 004 | TABLET;ORAL | 2MG | 1 | ADEMPAS | RIOCIGUAT |
| 005 | TABLET;ORAL | 2.5MG | 1 | ADEMPAS | RIOCIGUAT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-05-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-02-23 | PRIORITY |
| REMS; REMS | SUPPL | 4 | AP | 2015-12-04 | N/A |
| REMS; REMS | SUPPL | 6 | AP | 2017-01-17 | N/A |
| REMS; REMS | SUPPL | 7 | AP | 2016-10-04 | N/A |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-02-23 | STANDARD |
| REMS; REMS | SUPPL | 9 | AP | 2018-12-06 | N/A |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2018-01-11 | STANDARD |
| REMS; REMS | SUPPL | 13 | AP | 2020-11-30 | N/A |
| REMS; REMS | SUPPL | 14 | AP | 2020-02-10 | N/A |
| LABELING; Labeling | SUPPL | 15 | AP | 2021-09-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 2 | Null | 6 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Orphan | 5 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
BAYER HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 204819
[companyName] => BAYER HLTHCARE
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/204819s015lbl.pdf#page=24"]
[products] => [{"drugName":"ADEMPAS","activeIngredients":"RIOCIGUAT","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ADEMPAS","activeIngredients":"RIOCIGUAT","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ADEMPAS","activeIngredients":"RIOCIGUAT","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ADEMPAS","activeIngredients":"RIOCIGUAT","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ADEMPAS","activeIngredients":"RIOCIGUAT","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204819s015lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2018","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204819s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/23\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204819s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/17\/2017","submission":"SUPPL-6","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204819s006lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204819s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/08\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204819s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/08\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/204819s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/204819Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204819Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/204819Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"09\/10\/2021","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204819s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/204819Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"02\/10\/2020","submission":"SUPPL-14","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204819Orig1s014ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2020","submission":"SUPPL-13","supplementCategories":"REMS - MODIFIED - D-N-A, REMS - MODIFIED - BIFURCATED","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204819Orig1s013ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/11\/2018","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204819s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204819Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/06\/2018","submission":"SUPPL-9","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204819s009ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204819s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204819Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"10\/04\/2016","submission":"SUPPL-7","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204819Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"01\/17\/2017","submission":"SUPPL-6","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/204819s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/204819Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2015","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204819Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/23\/2015","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/06\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204819s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204819Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"06\/11\/2014","submission":"SUPPL-1","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204819Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[actionDate] => 2021-09-10
)
)