APPLICATION
ANDA076430
TYPE
ANDA
ORIGINAL APPROVAL
2004-02-11
LATEST ACTION
2019-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BENAZEPRIL HYDROCHLORIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 10MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 20MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 5MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEDiscontinued
BENAZEPRIL HYDROCHLORIDE 40MG · TABLET · ORAL
Approval history
2019-04-02Labeling · Supplement 12 · standardAP
2017-11-28Labeling · Supplement 11 · standardAP
2015-10-29Labeling · Supplement 10 · standardAP
2015-04-22Labeling · Supplement 9 · standardAP
2015-04-22Labeling · Supplement 8 · standardAP
2012-11-08Labeling · Supplement 7 · standardAP
2011-11-30Labeling · Supplement 6AP
2008-01-15Labeling · Supplement 5AP
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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