APPLICATION
ANDA076118
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2020-07-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 40MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2020-07-06Labeling · Supplement 24 · standardAP
2015-11-12Labeling · Supplement 20 · standardAP
2015-11-12Labeling · Supplement 21 · standardAP
2014-09-24Labeling · Supplement 19 · standardAP
2012-11-08Labeling · Supplement 18 · standardAP
2010-10-26Manufacturing (CMC) · Supplement 17AP
2010-04-13Labeling · Supplement 16AP
2008-10-20Labeling · Supplement 15AP
2008-08-22Labeling · Supplement 13AP
2007-09-25Labeling · 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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