← FDA DRUG APPROVALS

FDA NDA · NDA204819

ADEMPAS

riociguat

Sponsor: BAYER HLTHCARE

APPLICATION
NDA204819
TYPE
NDA
ORIGINAL APPROVAL
2013-10-08
LATEST ACTION
2026-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ADEMPAS · ReferencePrescription
RIOCIGUAT 1MG · TABLET · ORAL
ADEMPAS · ReferencePrescription
RIOCIGUAT 2.5MG · TABLET · ORAL
ADEMPAS · ReferencePrescription
RIOCIGUAT 1.5MG · TABLET · ORAL
ADEMPAS · ReferencePrescription
RIOCIGUAT 0.5MG · TABLET · ORAL
ADEMPAS · ReferencePrescription
RIOCIGUAT 2MG · TABLET · ORAL

Approval history

2026-05-08REMS · Supplement 20 — Letter ↗AP
2021-09-10Labeling · Supplement 15 · standard — Label ↗AP
2020-11-30REMS · Supplement 13 — Letter ↗AP
2020-02-10REMS · Supplement 14 — Letter ↗AP
2018-12-06REMS · Supplement 9 — Letter ↗AP
2018-01-11Efficacy · Supplement 11 · standard — Letter ↗AP
2017-02-23Labeling · Supplement 8 · standard — Label ↗AP
2017-01-17REMS · Supplement 6 — Letter ↗AP
2016-10-04REMS · Supplement 7 — Letter ↗AP
2015-12-04REMS · Supplement 4 — Letter ↗AP
2015-02-23Manufacturing (CMC) · Supplement 3 · priorityAP
2014-06-11REMS · Supplement 1 — Letter ↗AP
2014-05-06Labeling · Supplement 2 · standard — Label ↗AP
2013-10-08Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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