← FDA DRUG APPROVALS

FDA NDA · NDA020364

LOTREL

amlodipine besylate and benazepril hydrochloride

Sponsor: SANDOZ

APPLICATION
NDA020364
TYPE
NDA
ORIGINAL APPROVAL
1995-03-03
LATEST ACTION
2021-04-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2021-04-21Labeling · Supplement 68 · standard — Letter ↗AP
2020-02-10Labeling · Supplement 66 · standard — Letter ↗AP
2017-07-21Labeling · Supplement 65 · standard — Label ↗AP
2017-01-27Manufacturing (CMC) · Supplement 64 · standardAP
2016-02-08Manufacturing (CMC) · Supplement 62 · standardAP
2015-06-16Manufacturing (CMC) · Supplement 59 · standardAP
2015-05-18Labeling · Supplement 61 · standard — Letter ↗AP
2015-04-22Labeling · Supplement 60 · standard — Label ↗AP
2014-12-31Labeling · Supplement 58 · standard — Letter ↗AP
2012-10-05Labeling · Supplement 56 · unknown — Letter ↗AP
2012-10-05Labeling · Supplement 57 · unknown — Label ↗AP
2012-01-19Labeling · Supplement 55 · unknown — Letter ↗AP
2011-10-28Labeling · Supplement 54 · unknown — Label ↗AP
2011-06-20Labeling · Supplement 52 · unknown — Letter ↗AP
2011-01-04Labeling · Supplement 50 · standard — Label ↗AP
2010-03-29Labeling · Supplement 47 · standard — Letter ↗AP
2009-12-22Manufacturing (CMC) · Supplement 48 · standard — Letter ↗AP
2009-10-28Labeling · Supplement 46 · standard — Label ↗AP
2007-08-31Manufacturing (CMC) · Supplement 39 — Label ↗AP
2007-02-23Labeling · Supplement 36 · standard — Letter ↗AP
2006-04-11Efficacy · Supplement 23 · standard — Label ↗AP
2004-08-11Labeling · Supplement 28 · standard — Letter ↗AP
2004-07-02Labeling · Supplement 24 · standard — Label ↗AP
2003-08-29Labeling · Supplement 14 · standard — Letter ↗AP
2002-10-25Manufacturing (CMC) · Supplement 20 · standardAP
2002-09-20Manufacturing (CMC) · Supplement 19 · standardAP
2002-06-20Efficacy · Supplement 16 · standard — Label ↗AP
2002-04-29Manufacturing (CMC) · Supplement 18 · standardAP
2001-12-12Manufacturing (CMC) · Supplement 17 · standardAP
2001-11-30Manufacturing (CMC) · Supplement 15 · standardAP
2000-11-02Manufacturing (CMC) · Supplement 13 · standardAP
2000-05-10Manufacturing (CMC) · Supplement 12 · standardAP
1999-06-16Labeling · Supplement 8 · standard — Review ↗AP
1999-04-28Manufacturing (CMC) · Supplement 11 · standardAP
1999-02-18Manufacturing (CMC) · Supplement 10 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 9 · standardAP
1997-03-14Labeling · Supplement 7 · standard — Review ↗AP
1996-04-29Labeling · Supplement 2 · standardAP
1995-11-17Manufacturing (CMC) · Supplement 5 · standardAP
1995-11-06Manufacturing (CMC) · Supplement 6 · standardAP
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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