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FDA ANDA · ANDA079047
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: PHARMOBEDIENT
APPLICATION
ANDA079047
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-05
LATEST ACTION
2023-12-27
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 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
Approval history
2023-12-27Labeling · Supplement 13 · standardAP
2023-12-27Labeling · Supplement 12 · standardAP
2020-02-21Labeling · Supplement 10 · standardAP
2016-01-04Labeling · Supplement 9 · standardAP
2016-01-04Labeling · Supplement 7 · standardAP
2016-01-04Labeling · Supplement 5 · standardAP
2014-11-04Labeling · Supplement 3 · standardAP
2011-12-31Labeling · Supplement 2AP
2011-08-29Labeling · Supplement 1AP
2011-07-05OriginalAP
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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