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FDA ANDA · ANDA078466
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: LUPIN PHARMS
APPLICATION
ANDA078466
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-05
LATEST ACTION
2020-02-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE 10MG, 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 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · 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 10MG · CAPSULE · ORAL
Approval history
2020-02-21Labeling · Supplement 20 · standardAP
2015-12-03Labeling · Supplement 17 · standardAP
2015-12-03Labeling · Supplement 13 · standardAP
2015-12-03Labeling · Supplement 14 · standardAP
2014-11-05Labeling · Supplement 9 · standardAP
2012-09-27Labeling · Supplement 8AP
2011-08-31Labeling · Supplement 6AP
2011-07-05OriginalAP
2010-10-04Labeling · Supplement 5AP
2010-02-05OriginalAP
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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