APPLICATION
ANDA200461
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2022-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IRBESARTANDiscontinued
IRBESARTAN 300MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 75MG · TABLET · ORAL
IRBESARTANDiscontinued
IRBESARTAN 150MG · TABLET · ORAL
Approval history
2022-08-04Labeling · Supplement 6 · standardAP
2018-11-02Labeling · Supplement 4 · standardAP
2012-09-27Not Applicable · 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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