APPLICATION
ANDA090351
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2025-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
Approval history
2025-11-28Labeling · Supplement 15 · standardAP
2022-04-05Labeling · Supplement 12 · standardAP
2022-04-05Labeling · Supplement 13 · standardAP
2021-06-04Labeling · Supplement 10 · standardAP
2021-06-04Labeling · Supplement 11 · standardAP
2019-08-07Labeling · Supplement 8 · standardAP
2019-08-07Labeling · Supplement 5 · standardAP
2017-06-08OriginalAP
2015-03-02Labeling · Supplement 2 · 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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