APPLICATION
ANDA076211
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2017-11-28
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
2017-11-28Labeling · Supplement 22 · standardAP
2015-10-19Labeling · Supplement 21 · standardAP
2015-04-22Labeling · Supplement 18 · standardAP
2015-04-22Labeling · Supplement 20 · standardAP
2015-04-22Labeling · Supplement 19 · standardAP
2012-11-08Labeling · Supplement 16 · standardAP
2012-11-08Labeling · Supplement 15AP
2011-07-22Labeling · Supplement 14AP
2010-01-28Labeling · Supplement 12AP
2009-05-27Labeling · Supplement 8AP
2009-03-20Labeling · Supplement 6AP
2008-11-19Labeling · Supplement 5AP
2008-04-29Labeling · Supplement 4AP
2006-12-19Labeling · Supplement 3AP
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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