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FDA ANDA · ANDA076688
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: AUROBINDO PHARMA USA
APPLICATION
ANDA076688
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2018-08-16
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
2018-08-16Labeling · Supplement 15 · standardAP
2016-03-24Labeling · Supplement 13 · standardAP
2015-04-22Labeling · Supplement 12 · standardAP
2015-04-22Labeling · Supplement 10 · standardAP
2011-09-21Labeling · Supplement 9AP
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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