APPLICATION
ANDA206194
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-14
LATEST ACTION
2026-05-15
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
2026-05-15Labeling · Supplement 9 · standardAP
2024-02-16Labeling · Supplement 7 · standardAP
2024-02-16Labeling · Supplement 6 · standardAP
2024-02-16Labeling · Supplement 4 · standardAP
2018-11-02Labeling · Supplement 2 · standardAP
2016-06-14UNKNOWN · Original · 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.