APPLICATION
ANDA091236
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2025-09-16
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
2025-09-16Labeling · Supplement 29 · standardAP
2021-12-08Labeling · Supplement 20 · standardAP
2021-12-08Labeling · Supplement 16 · standardAP
2021-05-06Labeling · Supplement 15 · standardAP
2018-11-02Labeling · Supplement 6 · standardAP
2016-12-06Labeling · Supplement 3 · standardAP
2012-10-15UNKNOWN · 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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