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FDA ANDA · ANDA090149
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Sponsor: DR REDDYS LABS INC
APPLICATION
ANDA090149
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-05
LATEST ACTION
2019-11-22
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
Approval history
2019-11-22Labeling · Supplement 8 · standardAP
2016-01-04Labeling · Supplement 6 · standardAP
2016-01-04Labeling · Supplement 7 · standardAP
2014-10-26Labeling · Supplement 4 · standardAP
2012-09-27Labeling · Supplement 3AP
2011-12-12Labeling · Supplement 2AP
2011-08-31Labeling · 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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