APPLICATION
ANDA203534
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-23
LATEST ACTION
2025-10-01
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
2025-10-01Labeling · Supplement 19 · standardAP
2022-11-01Labeling · Supplement 16 · standardAP
2020-11-30Labeling · Supplement 6 · standardAP
2016-12-02Labeling · Supplement 1 · standardAP
2015-02-23UNKNOWN · 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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