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FDA ANDA · ANDA090364
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: WATSON LABS INC
APPLICATION
ANDA090364
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-05
LATEST ACTION
2020-04-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPrescription
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
Approval history
2020-04-17Labeling · Supplement 12 · standardAP
2020-04-17Labeling · Supplement 10 · standardAP
2020-04-17Labeling · Supplement 11 · standardAP
2014-11-05Labeling · Supplement 6 · standardAP
2012-09-27Labeling · Supplement 2 · standardAP
2011-08-19Labeling · 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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