FDA ANDA · ANDA091431
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: HERITAGE
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APPLICATION
ANDA091431
TYPE
ANDA
ORIGINAL APPROVAL
2013-12-30
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
Approval history
2026-10-14Labeling · Supplement 7 · standardAP
2020-09-08Labeling · Supplement 4 · standardAP
2020-02-21Labeling · Supplement 3 · standardAP
2016-01-04Labeling · Supplement 1 · standardAP
2016-01-04Labeling · Supplement 2 · standardAP
2013-12-30OriginalAP
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