APPLICATION
ANDA211195
TYPE
ANDA
ORIGINAL APPROVAL
2024-01-09
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 3AP
2024-12-12REMS · Supplement 2AP
2024-04-11REMS · 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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