APPLICATION
ANDA209509
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-10
LATEST ACTION
2025-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMBRISENTANDiscontinued
AMBRISENTAN 5MG · TABLET · ORAL
AMBRISENTANDiscontinued
AMBRISENTAN 10MG · TABLET · ORAL
Approval history
2025-04-04REMS · Supplement 6AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.