APPLICATION
ANDA076344
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2020-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 40MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2020-06-24Labeling · Supplement 18 · standardAP
2017-12-14Labeling · Supplement 17 · standardAP
2015-10-19Labeling · Supplement 16 · standardAP
2015-04-17Labeling · Supplement 15 · standardAP
2015-04-17Labeling · Supplement 13 · standardAP
2015-04-17Labeling · Supplement 14 · standardAP
2012-11-08Labeling · Supplement 11AP
2012-11-08Labeling · Supplement 12 · standardAP
2007-06-27Labeling · Supplement 8AP
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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