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FDA ANDA · ANDA076342
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Sponsor: ANI PHARMS
APPLICATION
ANDA076342
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2023-12-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 25MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG, HYDROCHLOROTHIAZIDE 12.5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEPrescription
BENAZEPRIL HYDROCHLORIDE 5MG, HYDROCHLOROTHIAZIDE 6.25MG · TABLET · ORAL
Approval history
2023-12-06Manufacturing (CMC) · Supplement 8 · unknownAP
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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