Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 204819
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADEMPAS RIOCIGUAT 0.5MG TABLET;ORAL Prescription None Yes No
ADEMPAS RIOCIGUAT 1MG TABLET;ORAL Prescription None Yes No
ADEMPAS RIOCIGUAT 1.5MG TABLET;ORAL Prescription None Yes No
ADEMPAS RIOCIGUAT 2MG TABLET;ORAL Prescription None Yes No
ADEMPAS RIOCIGUAT 2.5MG TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/08/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204819Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204819Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s008ltr.pdf
10/04/2016 SUPPL-7 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204819Orig1s007ltr.pdf
01/17/2017 SUPPL-6 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204819Orig1s006ltr.pdf
12/04/2015 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204819Orig1s004ltr.pdf
02/23/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/06/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s002ltr.pdf
06/11/2014 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204819Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s008lbl.pdf
01/17/2017 SUPPL-6 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204819s006lbl.pdf
05/06/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204819s002lbl.pdf
10/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204819s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English