APPLICATION
ANDA077446
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2026-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEPrescription
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
Approval history
2026-06-08Labeling · Supplement 15 · standardAP
2022-04-05Labeling · Supplement 14 · standardAP
2022-04-05Labeling · Supplement 13 · standardAP
2021-06-04Labeling · Supplement 12 · standardAP
2021-06-04Labeling · Supplement 11 · standardAP
2019-08-05Labeling · Supplement 9 · standardAP
2019-08-05Labeling · Supplement 10 · standardAP
2019-08-05Labeling · Supplement 8 · standardAP
2015-02-18Labeling · Supplement 7 · standardAP
2015-02-18Labeling · 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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