APPLICATION
ANDA077969
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-27
LATEST ACTION
2023-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
Approval history
2023-10-10Labeling · Supplement 8 · standardAP
2023-10-10Labeling · Supplement 10 · standardAP
2020-03-23Labeling · Supplement 7 · standardAP
2016-09-27Labeling · Supplement 6 · standardAP
2016-07-20OriginalAP
2015-02-18Labeling · Supplement 4 · standardAP
2013-08-30Labeling · Supplement 1 · 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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