APPLICATION
ANDA201505
TYPE
ANDA
ORIGINAL APPROVAL
2012-10-15
LATEST ACTION
2015-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, None (Tentative Approval)
Products
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN HYDROCHLOROTHIAZIDENone (Tentative Approval)
HYDROCHLOROTHIAZIDE 25MG, IRBESARTAN 300MG · TABLET · ORAL
IRBESARTAN AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 12.5MG, IRBESARTAN 150MG · TABLET · ORAL
Approval history
2015-02-17Labeling · Supplement 4 · standardAP
2015-02-17Labeling · Supplement 2 · standardAP
2012-10-15Not Applicable · OriginalAP
2012-10-15Not Applicable · OriginalTA
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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