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FDA ANDA · ANDA078212

BENAZEPRIL HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA078212
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-22
LATEST ACTION
2026-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 20MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 40MG · TABLET · ORAL
BENAZEPRIL HYDROCHLORIDEPrescription
BENAZEPRIL HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

2026-01-13Manufacturing (CMC) · Supplement 28 · unknownAP
2019-04-02Labeling · Supplement 17 · standardAP
2018-09-25Labeling · Supplement 16 · standardAP
2015-11-12Labeling · Supplement 15 · standardAP
2015-04-28Labeling · Supplement 14 · standardAP
2015-04-28Labeling · Supplement 10 · standardAP
2015-04-28Labeling · Supplement 13 · standardAP
2012-11-08Labeling · Supplement 9 · standardAP
2012-11-08Labeling · Supplement 8AP
2011-09-21Labeling · Supplement 6AP
2009-12-24Labeling · Supplement 4AP
2009-06-12Labeling · Supplement 2AP
2008-08-18Labeling · Supplement 1AP
2008-05-22Original — 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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