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FDA ANDA · ANDA076333

BENAZEPRIL HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA076333
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 11 · standardAP
2005-05-18Labeling · Supplement 6AP
2004-02-11OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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