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FDA ANDA · ANDA078794
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: APOTEX
APPLICATION
ANDA078794
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-21
LATEST ACTION
2024-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 10MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
Approval history
2024-08-22Labeling · Supplement 6 · standardAP
2024-03-27Labeling · Supplement 5 · standardAP
2018-08-16Labeling · Supplement 4 · standardAP
2016-01-26Labeling · Supplement 2 · standardAP
2016-01-26Labeling · Supplement 3 · standardAP
2014-08-21OriginalAP
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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