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FDA ANDA · ANDA077483
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA077483
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-08
LATEST ACTION
2019-11-07
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
2019-11-07Labeling · Supplement 10 · standardAP
2019-11-07Labeling · Supplement 9 · standardAP
2016-03-24Labeling · Supplement 8 · standardAP
2015-04-06Labeling · Supplement 7 · standardAP
2014-09-23Labeling · Supplement 6 · standardAP
2014-09-23Labeling · Supplement 5AP
2005-09-08OriginalAP
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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