APPLICATION
ANDA205699
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-26
LATEST ACTION
2026-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BOSENTANDiscontinued
BOSENTAN 62.5MG · TABLET · ORAL
BOSENTANDiscontinued
BOSENTAN 125MG · TABLET · ORAL
Approval history
2026-03-03REMS · Supplement 8AP
2025-11-05REMS · Supplement 7AP
2025-02-21REMS · Supplement 5AP
2024-09-17REMS · Supplement 4AP
2022-04-29REMS · Supplement 3AP
2019-11-04Labeling · 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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