APPLICATION
ANDA211135
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-01
LATEST ACTION
2026-05-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RIOCIGUATPrescription
RIOCIGUAT 2.5MG · TABLET · ORAL
RIOCIGUATPrescription
RIOCIGUAT 1.5MG · TABLET · ORAL
RIOCIGUATPrescription
RIOCIGUAT 0.5MG · TABLET · ORAL
RIOCIGUATPrescription
RIOCIGUAT 2MG · TABLET · ORAL
RIOCIGUATPrescription
RIOCIGUAT 1MG · TABLET · ORAL
Approval history
2026-05-08REMS · Supplement 1AP
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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