Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 204819
Company: BAYER HLTHCARE

Medication Guide

REMS

REMS

Summary Review

Products on NDA 204819

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADEMPAS	RIOCIGUAT	0.5MG	TABLET;ORAL	Prescription	AB	Yes	No
ADEMPAS	RIOCIGUAT	1MG	TABLET;ORAL	Prescription	AB	Yes	No
ADEMPAS	RIOCIGUAT	1.5MG	TABLET;ORAL	Prescription	AB	Yes	No
ADEMPAS	RIOCIGUAT	2MG	TABLET;ORAL	Prescription	AB	Yes	No
ADEMPAS	RIOCIGUAT	2.5MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204819

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
09/10/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204819Orig1s015ltr.pdf
02/10/2020	SUPPL-14	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s014ltr.pdf
11/30/2020	SUPPL-13	REMS - MODIFIED - D-N-A, REMS - MODIFIED - BIFURCATED	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s013ltr.pdf
01/11/2018	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819Orig1s011ltr.pdf
12/06/2018	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204819s009ltr.pdf
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

Labels for NDA 204819

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
09/10/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf
01/11/2018	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204819s011lbl.pdf
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

Therapeutic Equivalents for NDA 204819

ADEMPAS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADEMPAS	RIOCIGUAT	0.5MG	TABLET;ORAL	Prescription	Yes	AB	204819	BAYER HLTHCARE
RIOCIGUAT	RIOCIGUAT	0.5MG	TABLET;ORAL	Prescription	No	AB	211135	MSN

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADEMPAS	RIOCIGUAT	1MG	TABLET;ORAL	Prescription	Yes	AB	204819	BAYER HLTHCARE
RIOCIGUAT	RIOCIGUAT	1MG	TABLET;ORAL	Prescription	No	AB	211135	MSN

TABLET;ORAL; 1.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADEMPAS	RIOCIGUAT	1.5MG	TABLET;ORAL	Prescription	Yes	AB	204819	BAYER HLTHCARE
RIOCIGUAT	RIOCIGUAT	1.5MG	TABLET;ORAL	Prescription	No	AB	211135	MSN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADEMPAS	RIOCIGUAT	2MG	TABLET;ORAL	Prescription	Yes	AB	204819	BAYER HLTHCARE
RIOCIGUAT	RIOCIGUAT	2MG	TABLET;ORAL	Prescription	No	AB	211135	MSN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADEMPAS	RIOCIGUAT	2.5MG	TABLET;ORAL	Prescription	Yes	AB	204819	BAYER HLTHCARE
RIOCIGUAT	RIOCIGUAT	2.5MG	TABLET;ORAL	Prescription	No	AB	211135	MSN