APPLICATION
ANDA211187
TYPE
ANDA
ORIGINAL APPROVAL
2026-06-08
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
MACITENTANPrescription
MACITENTAN 10MG · TABLET · ORAL
Approval history
2026-06-08UNKNOWN · Original · standardAP
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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