APPLICATION
ANDA077205
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-14
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IRBESARTANPrescription
IRBESARTAN 75MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 150MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 300MG · TABLET · ORAL
Approval history
2026-07-13Labeling · Supplement 2 · standardAP
2015-11-18Labeling · Supplement 1 · standardAP
2012-11-14OriginalAP
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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