APPLICATION
ANDA077466
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2021-12-21
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
2021-12-21Labeling · Supplement 11 · standardAP
2021-08-30Labeling · Supplement 10 · standardAP
2021-05-06Labeling · Supplement 9 · standardAP
2020-12-10Labeling · Supplement 8 · standardAP
2015-11-05Labeling · Supplement 6 · standardAP
2012-09-27OriginalAP
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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