APPLICATION
ANDA077128
TYPE
ANDA
ORIGINAL APPROVAL
2006-03-08
LATEST ACTION
2019-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 40MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2019-04-02Labeling · Supplement 15 · standardAP
2017-12-14Labeling · Supplement 14 · standardAP
2016-01-21Labeling · Supplement 13 · standardAP
2015-05-01Labeling · Supplement 10 · standardAP
2015-05-01Labeling · Supplement 11 · standardAP
2014-09-24Labeling · Supplement 9 · standardAP
2014-09-24Labeling · Supplement 8 · standardAP
2012-11-08Labeling · Supplement 7AP
2010-11-30Labeling · Supplement 6AP
2009-01-21Labeling · Supplement 4AP
2008-04-29Labeling · Supplement 2AP
2006-03-08OriginalAP
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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