APPLICATION
ANDA209324
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-26
LATEST ACTION
2026-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BOSENTANPrescription
BOSENTAN 62.5MG · TABLET · ORAL
BOSENTANPrescription
BOSENTAN 125MG · TABLET · ORAL
Approval history
2026-04-01Labeling · Supplement 18 · standardAP
2026-04-01Labeling · Supplement 19 · standardAP
2026-04-01Labeling · Supplement 13 · standardAP
2026-03-03REMS · Supplement 20AP
2025-11-05REMS · Supplement 16AP
2025-02-21REMS · Supplement 14AP
2024-09-17REMS · Supplement 10AP
2024-08-19Labeling · Supplement 9 · standardAP
2024-08-19Labeling · Supplement 7 · standardAP
2022-04-29REMS · Supplement 6AP
2019-11-01Labeling · Supplement 1 · 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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