APPLICATION
ANDA203071
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2023-03-15
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
2023-03-15Labeling · Supplement 9 · standardAP
2021-09-15Labeling · Supplement 7 · standardAP
2021-09-15Labeling · Supplement 8 · standardAP
2020-08-13Labeling · Supplement 5 · standardAP
2016-08-22Labeling · Supplement 3 · standardAP
2015-11-17Labeling · Supplement 1 · 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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