APPLICATION
ANDA208252
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-28
LATEST ACTION
2026-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMBRISENTANPrescription
AMBRISENTAN 5MG · TABLET · ORAL
AMBRISENTANPrescription
AMBRISENTAN 10MG · TABLET · ORAL
Approval history
2026-02-17Labeling · Supplement 8 · standardAP
2025-04-04REMS · Supplement 7AP
2024-08-19REMS · Supplement 5AP
2021-06-08REMS · Supplement 4AP
2020-12-22REMS · Supplement 2AP
2019-11-29Labeling · 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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