APPLICATION
ANDA091370
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2026-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
Approval history
2026-01-14Labeling · Supplement 38 · standardAP
2023-08-25Labeling · Supplement 28 · standardAP
2023-08-25Labeling · Supplement 30 · standardAP
2021-06-04Labeling · Supplement 26 · standardAP
2021-06-04Labeling · Supplement 23 · standardAP
2019-04-25Labeling · Supplement 8 · standardAP
2019-04-25Labeling · Supplement 13 · standardAP
2013-08-29Labeling · Supplement 1 · standardAP
2012-10-15OriginalAP
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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