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FDA ANDA · ANDA077179

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Sponsor: TEVA PHARMS

APPLICATION
ANDA077179
TYPE
ANDA
ORIGINAL APPROVAL
2007-05-18
LATEST ACTION
2019-09-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 10MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 40MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 5MG BASE, BENAZEPRIL HYDROCHLORIDE 20MG · CAPSULE · ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDiscontinued
AMLODIPINE BESYLATE EQ 2.5MG BASE, BENAZEPRIL HYDROCHLORIDE 10MG · CAPSULE · ORAL

Approval history

2019-09-18Labeling · Supplement 26 · standardAP
2016-01-04Labeling · Supplement 24 · standardAP
2016-01-04Labeling · Supplement 22 · standardAP
2016-01-04Labeling · Supplement 23 · standardAP
2014-10-26Labeling · Supplement 20 · standardAP
2012-05-23Manufacturing (CMC) · Supplement 14AP
2012-02-23Labeling · Supplement 19AP
2011-12-31Labeling · Supplement 17AP
2011-08-31Labeling · Supplement 16AP
2011-07-05Labeling · Supplement 6AP
2011-07-05Supplement 5AP
2011-04-22Labeling · Supplement 11AP
2011-01-13Labeling · Supplement 8AP
2010-01-24Labeling · Supplement 9AP
2007-07-16Labeling · Supplement 1AP
2007-05-18Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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