APPLICATION
ANDA210784
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-28
LATEST ACTION
2026-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMBRISENTANDiscontinued
AMBRISENTAN 10MG · TABLET · ORAL
AMBRISENTANDiscontinued
AMBRISENTAN 5MG · TABLET · ORAL
Approval history
2026-01-18Labeling · Supplement 14 · standardAP
2026-01-18Labeling · Supplement 9 · standardAP
2025-04-04REMS · Supplement 13AP
2024-08-19REMS · Supplement 10AP
2021-06-08REMS · Supplement 6AP
2020-12-22REMS · Supplement 4AP
2019-11-06Labeling · 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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