APPLICATION
ANDA211224
TYPE
ANDA
ORIGINAL APPROVAL
2021-04-06
LATEST ACTION
2025-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MACITENTANPrescription
MACITENTAN 10MG · TABLET · ORAL
Approval history
2025-04-02REMS · Supplement 4AP
2024-12-12REMS · Supplement 3AP
2024-04-11REMS · Supplement 2AP
2023-02-01REMS · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.