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FDA ANDA · ANDA202239

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA202239
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-05
LATEST ACTION
2023-03-15
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

2023-03-15Labeling · Supplement 18 · standardAP
2020-10-13Labeling · Supplement 14 · standardAP
2020-02-21Labeling · Supplement 10 · standardAP
2016-01-04Labeling · Supplement 8 · standardAP
2016-01-04Labeling · Supplement 6 · standardAP
2014-10-31Labeling · Supplement 3 · standardAP
2014-10-31Labeling · Supplement 1 · standardAP
2012-09-05OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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