APPLICATION
ANDA203081
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2025-11-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IRBESARTANPrescription
IRBESARTAN 150MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 300MG · TABLET · ORAL
IRBESARTANPrescription
IRBESARTAN 75MG · TABLET · ORAL
Approval history
2025-11-12Labeling · Supplement 22 · standardAP
2021-12-20Labeling · Supplement 19 · standardAP
2021-09-01Labeling · Supplement 18 · standardAP
2021-05-06Labeling · Supplement 17 · standardAP
2018-12-13Labeling · Supplement 11 · standardAP
2016-08-09Labeling · Supplement 8 · standardAP
2014-09-22Manufacturing (CMC) · Supplement 4 · unknownAP
2014-09-15Labeling · Supplement 6 · standardAP
2012-09-27UNKNOWN · 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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