APPLICATION
ANDA202254
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-03
LATEST ACTION
2025-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IRBESARTANPrescription
IRBESARTAN 300MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 75MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 150MG · TABLET · ORAL
Approval history
2025-11-25Labeling · Supplement 62 · standardAP
2021-12-08Labeling · Supplement 37 · standardAP
2021-12-08Labeling · Supplement 41 · standardAP
2021-05-06Labeling · Supplement 34 · standardAP
2018-10-24Labeling · Supplement 21 · standardAP
2016-08-09Labeling · Supplement 11 · standardAP
2015-12-28Labeling · Supplement 6 · standardAP
2013-03-11Manufacturing (CMC) · Supplement 2 · unknownAP
2012-10-03OriginalAP
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.