APPLICATION
ANDA076402
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2018-09-24
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
2018-09-24Labeling · Supplement 20 · standardAP
2016-01-04Labeling · Supplement 17 · standardAP
2016-01-04Labeling · Supplement 18 · standardAP
2014-09-23Labeling · Supplement 13 · standardAP
2012-11-08Labeling · Supplement 11 · standardAP
2012-11-08Labeling · Supplement 9AP
2010-03-23Labeling · Supplement 8AP
2009-03-31Labeling · Supplement 7AP
2007-09-18Labeling · Supplement 6AP
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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