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FDA ANDA · ANDA078381
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: CHARTWELL RX
APPLICATION
ANDA078381
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-29
LATEST ACTION
2023-04-06
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2023-04-06Labeling · Supplement 10 · standardAP
2014-10-24Labeling · Supplement 7 · standardAP
2012-09-27Labeling · Supplement 6AP
2011-11-29Labeling · Supplement 5AP
2011-08-31Labeling · Supplement 4AP
2011-02-16Labeling · Supplement 2AP
2010-07-29OriginalAP
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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