APPLICATION
ANDA213981
TYPE
ANDA
ORIGINAL APPROVAL
2026-02-17
LATEST ACTION
2026-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
BOSENTANPrescription
BOSENTAN 32MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2026-03-03REMS · Supplement 1AP
2026-02-17UNKNOWN · 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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