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FDA ANDA · ANDA078848

BENAZEPRIL HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
ANDA078848
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-23
LATEST ACTION
2019-08-07
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

2019-08-07Labeling · Supplement 5 · standardAP
2018-10-09Labeling · Supplement 4 · standardAP
2016-12-21Labeling · Supplement 3 · standardAP
2011-08-12Labeling · Supplement 1AP
2008-05-23Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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