APPLICATION
ANDA216531
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-21
LATEST ACTION
2025-07-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMBRISENTANPrescription
AMBRISENTAN 10MG · TABLET · ORAL
AMBRISENTANPrescription
AMBRISENTAN 5MG · TABLET · ORAL
Approval history
2025-07-18Labeling · Supplement 3 · standardAP
2025-04-04REMS · Supplement 2AP
2024-08-19REMS · Supplement 1AP
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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