APPLICATION
ANDA201531
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IRBESARTANDiscontinued
IRBESARTAN 150MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 300MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 75MG · TABLET · ORAL
Approval history
2025-09-16Labeling · Supplement 14 · standardAP
2021-12-03Labeling · Supplement 12 · standardAP
2021-09-14Labeling · Supplement 10 · standardAP
2021-09-14Labeling · Supplement 11 · standardAP
2019-04-23Labeling · Supplement 6 · standardAP
2016-08-22Labeling · Supplement 4 · standardAP
2015-10-15Labeling · Supplement 3 · standardAP
2012-10-15Not Applicable · OriginalAP
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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