Amlodipine / benazepril Oral Capsule

Brand(s)
Lotrel
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-05-07)
Oldest Current Product
1995-03-03
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\AMLODIPINE:BENAZEPRIL
FDAOB
ORAL\CAPSULE\AMLODIPINE BESYLATE: BENAZEPRIL HYDROCHLORIDE
SPL Active
ORAL\CAPSULE\AMLODIPINE BESYLATE: BENAZEPRIL HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE\AMLODIPINE: BENAZEPRIL
ORAL\CAPSULE\AMLODIPINE: BENAZEPRILAT

product(s) by strength(s)

amlodipine 10 mg / benazepril hydrochloride 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780364LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937373ANDATeva Pharmaceuticals Usa Inc2007-05-18AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786898ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0773755cb15b9d-1c45-4491-bfcc-a902a491b288
3005913760ANDAWatson Laboratories, Inc.2010-10-13AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077890776a1619-c3af-65ff-a5ad-2cd807656205
4007812274NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840932ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110341ANDADr. Reddy'S Laboratories Ltd2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077183ca014f06-982c-6fe1-9948-a3701dd35d34
7572370146ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053118ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620586ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010130ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151399NDANcs Healthcare Of Ky, Inc Dba Vangard Labs1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812274NDA0203646b5efcb5-7f6c-4264-8623-8ce100889c2c
2216950916ANDARebel Distributors Corp2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110341ANDA07718343464a6b-a3b8-445b-b020-cf60f0b5e8a4
3332610825ANDAAidarex Pharmaceuticals Llc2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110341ANDA07718302209439-fe92-42de-81e3-51a8288debc0
4430630232NDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812274NDA0203646bb6b9a0-8de1-47cc-8534-7d1852d4243b
5548684870LotrelNDAPhysicians Total Care, Inc.2003-07-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780364NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
6557000011NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812274NDA02036435bf4392-eb96-4091-b7e9-50c1f2e52467
7581182274NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812274NDA0203641c20ce12-06d3-4060-9936-ea847a525053
8680840726ANDAAmerican Health Packaging2014-06-02AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110341ANDA077183563eff16-a16f-470c-94ca-08877e4d42f7

amlodipine 10 mg / benazepril hydrochloride 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780379LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937671ANDATeva Pharmaceuticals Usa Inc2011-07-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786900ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0790475cb15b9d-1c45-4491-bfcc-a902a491b288
3005913762ANDAWatson Laboratories, Inc.2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA090364fe4734a2-6219-8bf5-9c3a-d392910db4dc
4007812279NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840953ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110586ANDADr. Reddy'S Laboratories Ltd2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA090149f12f18bb-7ddb-e7dc-4edd-32f4ac212bca
7572370147ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053226ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620587ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010131ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422540074ANDARebel Distributors Corp2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110586ANDA09014915f7cde7-8dc2-4b07-83a9-9b86d6ec7f43
2548685690LotrelNDAPhysicians Total Care, Inc.2006-10-10AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780379NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
3548686297ANDAPhysicians Total Care, Inc.2011-08-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110586ANDA090149c95fe9f4-fb64-41b1-a61f-85b102d09929
4551549668LotrelNDACardinal Health1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780379NDA020364e11652b8-6ce6-4366-9519-a43a0d36f235
5557000012NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812279NDA02036435bf4392-eb96-4091-b7e9-50c1f2e52467
6581182279NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812279NDA0203641c20ce12-06d3-4060-9936-ea847a525053

amlodipine 2.5 mg / benazepril hydrochloride 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780404LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937370ANDATeva Pharmaceuticals Usa Inc2007-05-18AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786895ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0773755cb15b9d-1c45-4491-bfcc-a902a491b288
3005913757ANDAWatson Laboratories, Inc.2010-10-13AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077890776a1619-c3af-65ff-a5ad-2cd807656205
4007812271NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840929ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110338ANDADr. Reddy'S Laboratories Ltd2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077183ca014f06-982c-6fe1-9948-a3701dd35d34
7572370142ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053115ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620582ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010132ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94
11681800755ANDALupin Pharmaceuticals, Inc.2010-02-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466968c611b-43a7-40f0-9ed3-aa67ee88364b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610823ANDAAidarex Pharmaceuticals Llc2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110338ANDA07718302209439-fe92-42de-81e3-51a8288debc0
2430630171NDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812271NDA02036448622cd3-1e25-4b08-b5bc-f2552e436d1f
3548684066LotrelNDAPhysicians Total Care, Inc.2005-02-02AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780404NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
4548685793ANDAPhysicians Total Care, Inc.2010-08-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800755ANDA07846656831e08-1445-4798-b661-0a780349085a
5581182271NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812271NDA0203641c20ce12-06d3-4060-9936-ea847a525053
6681511363NDA AUTHORIZED GENERICCarilion Materials Management1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812271NDA020364224e9b5b-fa1f-452d-8ce7-d630b18f967f

amlodipine 5 mg / benazepril hydrochloride 10 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780405LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937371ANDATeva Pharmaceuticals Usa Inc2007-05-18AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786896ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0773755cb15b9d-1c45-4491-bfcc-a902a491b288
3005913758ANDAWatson Laboratories, Inc.2010-10-13AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077890776a1619-c3af-65ff-a5ad-2cd807656205
4007812272NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840930ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110339ANDADr. Reddy'S Laboratories Ltd2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077183ca014f06-982c-6fe1-9948-a3701dd35d34
7572370143ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053116ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620583ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010133ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151397NDANcs Healthcare Of Ky, Inc Dba Vangard Labs1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812272NDA0203646b5efcb5-7f6c-4264-8623-8ce100889c2c
2216950866ANDARebel Distributors Corp2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110339ANDA077183241e7477-ecae-4f84-8410-bbfaa9f57ed0
3332610824ANDAAidarex Pharmaceuticals Llc2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110339ANDA0771834da56a43-99aa-46df-aafc-ea193c46e442
4353560917NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812272NDA020364630a292e-ec00-48f1-8aa8-00fbd176b187
5430630233NDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812272NDA020364831c406d-1ba2-48f5-84ed-7d96b290cc18
6521250769ANDARemedyrepack Inc.2013-11-12AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800756ANDA07846617261391-6671-4462-93da-24dd36d4af96
7548684073LotrelNDAPhysicians Total Care, Inc.1999-07-01AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780405NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
8552890096LotrelNDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780405NDA0203642bd2b07b-0da6-47a2-858b-e18851d566fb
9581182272NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812272NDA0203641c20ce12-06d3-4060-9936-ea847a525053
10636294878ANDABryant Ranch Prepack2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE498840930ANDA078381f3817371-3b20-4437-8fdb-8e3dd95863ea
11681511364ANDACarilion Materials Management2010-02-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800756ANDA078466e59a70d3-d9f2-43ea-92e7-271a2b2d4b1a

amlodipine 5 mg / benazepril hydrochloride 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780406LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937372ANDATeva Pharmaceuticals Usa Inc2007-05-18AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786897ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0773755cb15b9d-1c45-4491-bfcc-a902a491b288
3005913759ANDAWatson Laboratories, Inc.2010-10-13AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077890776a1619-c3af-65ff-a5ad-2cd807656205
4007812273NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840931ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110340ANDADr. Reddy'S Laboratories Ltd2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077183ca014f06-982c-6fe1-9948-a3701dd35d34
7572370144ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053117ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620584ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010134ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151398NDANcs Healthcare Of Ky, Inc Dba Vangard Labs1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812273NDA0203646b5efcb5-7f6c-4264-8623-8ce100889c2c
2332610982ANDAAidarex Pharmaceuticals Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE658620584ANDA202239178f8088-43ef-4e2c-a108-d86cd43df1ae
3353560960NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812273NDA020364653623d7-ed10-4505-a32d-6360d3be8b3d
4430630234NDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812273NDA02036498c34c61-4965-427e-8eea-42f8a15dd79d
5430630402ANDAPd-Rx Pharmaceuticals, Inc.2007-05-21AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000937372ANDA077179b294ae51-53a3-4a58-9c30-3e8268cc8536
6430630571ANDAPd-Rx Pharmaceuticals, Inc.2010-02-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800757ANDA078466c7ce768a-4a31-49e5-b47b-616e05a2fb99
7521250772ANDARemedyrepack Inc.2014-02-18AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800757ANDA078466bd3f7aa4-4b0a-464f-920e-7285acebc6ea
8548684074LotrelNDAPhysicians Total Care, Inc.2000-11-28AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780406NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
9552890039LotrelNDAPd-Rx Pharmaceuticals, Inc.1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780406NDA0203641dd4f8bf-51cc-468f-a1cb-2427a8c71ad7
10581182273NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812273NDA0203641c20ce12-06d3-4060-9936-ea847a525053
11636291454ANDABryant Ranch Prepack2010-04-19AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110340ANDA07718315416229-d7d3-5bfb-a373-71575c36d5cf
12681511365NDA AUTHORIZED GENERICCarilion Materials Management1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812273NDA020364f40161f0-7b9e-4131-92d6-893cb9473e71

amlodipine 5 mg / benazepril hydrochloride 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780384LotrelNDANovartis Pharmaceuticals Corporation1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA02036494ae6054-b7ae-4212-a567-4f803af8f2c7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937670ANDATeva Pharmaceuticals Usa Inc2011-07-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA077179e4682a6e-9624-48b0-978f-95da00cfb78f
2003786899ANDAMylan Pharmaceuticals Inc.2012-02-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA0790475cb15b9d-1c45-4491-bfcc-a902a491b288
3005913761ANDAWatson Laboratories, Inc.2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA090364fe4734a2-6219-8bf5-9c3a-d392910db4dc
4007812277NDA AUTHORIZED GENERICSandoz Inc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULENDA0203646d0c2df4-e9db-4622-95e8-33aa8a08f593
5498840952ANDAPar Pharmaceutical Companies, Inc.2011-01-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078381f7378a01-f825-4905-9134-6ff13cac10c9
6551110587ANDADr. Reddy'S Laboratories Ltd2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA090149f12f18bb-7ddb-e7dc-4edd-32f4ac212bca
7572370145ANDACitron Pharma Llc2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223903b175fc-d430-490d-b7ac-9f7a2cb1dd8b
8605053225ANDAApotex Corp2013-12-30AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA091431254b2202-b14d-9279-8311-cabcb0e75fc8
9658620585ANDAAurobindo Pharma Limited2012-09-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA20223999ed4927-9a34-4e8d-8eea-60b63c867d46
10680010135ANDABluepoint Laboratories2015-07-16AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULEANDA078466df8e23c8-6c8f-4293-8a37-5ad3d48dba94

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560965NDA AUTHORIZED GENERICLake Erie Medical Dba Quality Care Products Llc1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812277NDA020364653623d7-ed10-4505-a32d-6360d3be8b3d
2422540073ANDARebel Distributors Corp2011-07-05AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE551110587ANDA09014915f7cde7-8dc2-4b07-83a9-9b86d6ec7f43
3521250768ANDARemedyrepack Inc.2013-11-12AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE681800759ANDA0784662d6d859b-e0c2-46f7-9bf5-f430d28ea12e
4548685783LotrelNDAPhysicians Total Care, Inc.2007-06-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000780384NDA0203644653cabc-f249-4b4e-95b6-5fb4ddc0ad5d
5581182277NDA AUTHORIZED GENERICClinical Solutions Wholesale1995-03-03AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE007812277NDA0203641c20ce12-06d3-4060-9936-ea847a525053
6636295366ANDABryant Ranch Prepack2011-07-20AMLODIPINE BESYLATE, BENAZEPRIL HYDROCHLORIDEORALCAPSULE000937670ANDA077179180506ee-0d90-4399-bc7b-fb1489951551

application(s)

#idtitleapplicantapprovedpatentapproved drug
1ANDA077179AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDETEVA PHARMACEUTICALS USA2007-05-18ANDA077179_001, ANDA077179_002, ANDA077179_003, ANDA077179_004, ANDA077179_005, ANDA077179_006
2ANDA077183AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABORATORIES INC2010-04-15ANDA077183_001, ANDA077183_002, ANDA077183_003, ANDA077183_004
3ANDA077375AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2010-05-21ANDA077375_001, ANDA077375_002, ANDA077375_003, ANDA077375_004
4ANDA077890AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABORATORIES INC2010-10-14ANDA077890_001, ANDA077890_002, ANDA077890_003, ANDA077890_004
5ANDA078381AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPAR PHARMACEUTICAL INC2010-07-29ANDA078381_001, ANDA078381_002, ANDA078381_003, ANDA078381_004, ANDA078381_005, ANDA078381_006
6ANDA078466AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELUPIN PHARMACEUTICALS INC2010-02-05ANDA078466_001, ANDA078466_002, ANDA078466_003, ANDA078466_004, ANDA078466_005, ANDA078466_006
7ANDA079047AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEMYLAN PHARMACEUTICALS INC2011-07-05ANDA079047_001, ANDA079047_002
8ANDA090149AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEDR REDDYS LABORATORIES INC2011-07-05ANDA090149_001, ANDA090149_002
9ANDA090364AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEWATSON LABORATORIES INC2011-07-05ANDA090364_001, ANDA090364_002
10ANDA091431AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAPOTEX INC2013-12-30ANDA091431_001, ANDA091431_002, ANDA091431_003, ANDA091431_004, ANDA091431_005, ANDA091431_006
11ANDA202239AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEAUROBINDO PHARMA LTD2012-09-05ANDA202239_001, ANDA202239_002, ANDA202239_003, ANDA202239_004, ANDA202239_005, ANDA202239_006
12NDA020364LOTRELNOVARTIS PHARMACEUTICALS CORP1995-03-03p6162802, TREATMENT OF CARDIOVASCULAR DISORDERS/ METHOD OF TREATING HYPERTENSION, SUBSTANCENDA020364_002, NDA020364_003, NDA020364_004, NDA020364_005, NDA020364_006, NDA020364_007

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077179_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2007-05-18AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
2ANDA077179_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2007-05-18AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
3ANDA077179_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2007-05-18AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
4ANDA077179_004RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2007-05-18AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
5ANDA077179_005RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
6ANDA077179_006RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
7ANDA077183_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-04-15AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
8ANDA077183_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-04-15AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
9ANDA077183_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-04-15AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
10ANDA077183_004RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-04-15AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
11ANDA077375_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-05-21AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
12ANDA077375_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-05-21AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
13ANDA077375_003RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2010-05-21AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
14ANDA077375_004RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2010-05-21AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
15ANDA077890_001RXBENAZEPRIL HYDROCHLORIDE (10MG), AMLODIPINE BESYLATE (EQ 2.5MG BASE)ORALCAPSULEFalseAB2010-10-14AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
16ANDA077890_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-10-14AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
17ANDA077890_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-10-14AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
18ANDA077890_004RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-10-14AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
19ANDA078381_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
20ANDA078381_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
21ANDA078381_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
22ANDA078381_004RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
23ANDA078381_005RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
24ANDA078381_006RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2010-07-29AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
25ANDA078466_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2010-02-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
26ANDA078466_002RXBENAZEPRIL HYDROCHLORIDE (10MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2010-02-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
27ANDA078466_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2010-02-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
28ANDA078466_004RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2010-02-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
29ANDA078466_005RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
30ANDA078466_006RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
31ANDA079047_001RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
32ANDA079047_002RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
33ANDA090149_001RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
34ANDA090149_002RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
35ANDA090364_001RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
36ANDA090364_002RXAMLODIPINE BESYLATE (EQ 10MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2011-07-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
37ANDA091431_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
38ANDA091431_002RXBENAZEPRIL HYDROCHLORIDE (10MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
39ANDA091431_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
40ANDA091431_004RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
41ANDA091431_005RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
42ANDA091431_006RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2013-12-30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
43ANDA202239_001RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
44ANDA202239_002RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
45ANDA202239_003RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
46ANDA202239_004RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
47ANDA202239_005RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
48ANDA202239_006RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2012-09-05AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
49NDA020364_002RXAMLODIPINE BESYLATE (EQ 2.5MG BASE), BENAZEPRIL HYDROCHLORIDE (10MG)ORALCAPSULEFalseAB1995-03-03LOTREL
50NDA020364_003RXBENAZEPRIL HYDROCHLORIDE (10MG), AMLODIPINE BESYLATE (EQ 5MG BASE)ORALCAPSULEFalseAB1995-03-03LOTREL
51NDA020364_004RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (20MG)ORALCAPSULEFalseAB1995-03-03LOTREL
52NDA020364_005RXBENAZEPRIL HYDROCHLORIDE (20MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULEFalseAB2002-06-20LOTREL
53NDA020364_006RXBENAZEPRIL HYDROCHLORIDE (40MG), AMLODIPINE BESYLATE (EQ 10MG BASE)ORALCAPSULETrueAB2006-04-11LOTREL
54NDA020364_007RXAMLODIPINE BESYLATE (EQ 5MG BASE), BENAZEPRIL HYDROCHLORIDE (40MG)ORALCAPSULEFalseAB2006-04-11LOTREL

patent(s)

#idexpiration dateapplication(s)
1p6162802 (view patent)2017-12-19NDA020364

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102209439-fe92-42de-81e3-51a8288debc0 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-151332610823, 332610825
203b175fc-d430-490d-b7ac-9f7a2cb1dd8b (view SPL)These highlights do not include all the information needed to use amlodipine and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine and benazepril hydrochloride capsules USP. AMLODIPINE and BENAZEPRIL hydrochloride capsules USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionCitron Pharma Llc2015-10-121572370142, 572370143, 572370144, 572370145, 572370146, 572370147
315416229-d7d3-5bfb-a373-71575c36d5cf (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackANALYSIS, MANUFACTURE, RELABEL, REPACK2010-04-192636291454
415f7cde7-8dc2-4b07-83a9-9b86d6ec7f43 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-12-201422540073, 422540074
517261391-6671-4462-93da-24dd36d4af96 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules.Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-121521250769
6178f8088-43ef-4e2c-a108-d86cd43df1ae (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride CapsulesInitial U.S. Approval: 1995prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-201332610982
7180506ee-0d90-4399-bc7b-fb1489951551 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules.AMLODIPINE besylate and BENAZEPRIL hydrochloride capsules for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-071000636295366
81c20ce12-06d3-4060-9936-ea847a525053 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-08-122581182271, 581182272, 581182273, 581182274, 581182277, 581182279
91dd4f8bf-51cc-468f-a1cb-2427a8c71ad7 (view SPL)These highlights do not include all the information needed to use Lotrelsafely and effectively. See full prescribing information for Lotrel. Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-1013552890039
10224e9b5b-fa1f-452d-8ce7-d630b18f967f (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-10-102681511363
11241e7477-ecae-4f84-8410-bbfaa9f57ed0 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-041216950866
12254b2202-b14d-9279-8311-cabcb0e75fc8 (view SPL)These highlights do not include all the information needed to use AMLODIPINE and BENAZEPRIL hydrochloride capsules, USP safely and effectively. See full prescribing information for AMLODIPINE and BENAZEPRIL hydrochloride capsules, USP. AMLODIPINE and BENAZEPRIL hydrochloride Capsules , USP for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionApotex Corpanalysis, manufacture2015-06-014605053115, 605053116, 605053117, 605053118, 605053225, 605053226
132bd2b07b-0da6-47a2-858b-e18851d566fb (view SPL)These highlights do not include all the information needed to use Lotrelsafely and effectively. See full prescribing information for Lotrel. Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-1013552890096
142d6d859b-e0c2-46f7-9bf5-f430d28ea12e (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules.Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2013-11-121521250768
1535bf4392-eb96-4091-b7e9-50c1f2e52467 (view SPL)These highlights do not include all the information needed to use see full prescribing information for and Initial U.S. ApprovalprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-09-231557000011, 557000012
1643464a6b-a3b8-445b-b020-cf60f0b5e8a4 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-07-201216950916
174653cabc-f249-4b4e-95b6-5fb4ddc0ad5d (view SPL)These highlights do not include all the information needed to use Lotrelsafely and effectively. See full prescribing information for Lotrel. Lotrel (amlodipine besylate and benazepril hydrochloride) Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-03-023548684066, 548684073, 548684074, 548684870, 548685690, 548685783
1848622cd3-1e25-4b08-b5bc-f2552e436d1f (view SPL)Amlodipine Besylate and Benazepril HydrochlorideprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-091430630171
194da56a43-99aa-46df-aafc-ea193c46e442 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-201332610824
20563eff16-a16f-470c-94ca-08877e4d42f7 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules.Amlodipine Besylate and Benazepril Hydrochloride CapsulesInitial U.S. Approval: 1995prescriptionHuman PrescriptionAmerican Health PackagingREPACK2012-11-011680840726
2156831e08-1445-4798-b661-0a780349085a (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-105548685793
225cb15b9d-1c45-4491-bfcc-a902a491b288 (view SPL)These highlights do not include all the information needed to use amlodipine and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine and benazepril hydrochloride capsules. AMLODIPINE and BENAZEPRIL hydrochloride capsules USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-3114003786895, 003786896, 003786897, 003786898, 003786899, 003786900
23630a292e-ec00-48f1-8aa8-00fbd176b187 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-201353560917
24653623d7-ed10-4505-a32d-6360d3be8b3d (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-281353560960, 353560965
256b5efcb5-7f6c-4264-8623-8ce100889c2c (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-05-0912006151397, 006151398, 006151399
266bb6b9a0-8de1-47cc-8534-7d1852d4243b (view SPL)Amlodipine Besylate and Benazepril HydrochlorideprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-091430630232
276d0c2df4-e9db-4622-95e8-33aa8a08f593 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionSandoz Inc2012-10-1011007812271, 007812272, 007812273, 007812274, 007812277, 007812279
28776a1619-c3af-65ff-a5ad-2cd807656205 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-02-0115005913757, 005913758, 005913759, 005913760
29831c406d-1ba2-48f5-84ed-7d96b290cc18 (view SPL)Amlodipine Besylate and Benazepril HydrochlorideprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-091430630233
3094ae6054-b7ae-4212-a567-4f803af8f2c7 (view SPL)These highlights do not include all the information needed to use LOTREL safely and effectively. See full prescribing information for LOTREL. LOTREL (amlodipine besylate and benazepril hydrochloride) Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-05-0717000780364, 000780379, 000780384, 000780404, 000780405, 000780406
31968c611b-43a7-40f0-9ed3-aa67ee88364b (view SPL)These highlights do not include all the information needed to use Amlodipine and Benazepril Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Amlodipine and Benazepril Hydrochloride Capsules, USP. AMLODIPINE and BENAZEPRIL Hydrochloride Capsules USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionLupin Pharmaceuticals, Inc.manufacture, pack2015-07-018681800755
3298c34c61-4965-427e-8eea-42f8a15dd79d (view SPL)Amlodipine Besylate and Benazepril HydrochlorideprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-05-091430630234
3399ed4927-9a34-4e8d-8eea-60b63c867d46 (view SPL)These highlights do not include all the information needed to use amlodipine and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine and benazepril hydrochloride capsules USP. AMLODIPINE and BENAZEPRIL hydrochloride capsules USP, for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-06-035658620582, 658620583, 658620584, 658620585, 658620586, 658620587
34b294ae51-53a3-4a58-9c30-3e8268cc8536 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules.AMLODIPINE besylate and BENAZEPRIL hydrochloride capsules for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-11-137430630402
35bd3f7aa4-4b0a-464f-920e-7285acebc6ea (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules.Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionRemedyrepack Inc.2014-02-185521250772
36c7ce768a-4a31-49e5-b47b-616e05a2fb99 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-09-027430630571
37c95fe9f4-fb64-41b1-a61f-85b102d09929 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-101548686297
38ca014f06-982c-6fe1-9948-a3701dd35d34 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. AMLODIPINE and BENAZEPRIL hydrochloride capsules USP, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-06-1811551110338, 551110339, 551110340, 551110341
39df8e23c8-6c8f-4293-8a37-5ad3d48dba94 (view SPL)These highlights do not include all the information needed to use Amlodipine and Benazepril Hydrochloride Capsules, USP safely and effectively. See full prescribing information for Amlodipine and Benazepril Hydrochloride Capsules, USP. AMLODIPINE and BENAZEPRIL Hydrochloride Capsules USP for oral useInitial U.S. Approval: 1995prescriptionHuman PrescriptionBluepoint LaboratoriesMANUFACTURE, PACK2015-07-166680010130, 680010131, 680010132, 680010133, 680010134, 680010135
40e11652b8-6ce6-4366-9519-a43a0d36f235 (view SPL)LotrelprescriptionHuman PrescriptionCardinal HealthREPACK2011-01-131551549668
41e4682a6e-9624-48b0-978f-95da00cfb78f (view SPL)These highlights do not include all the information needed to use amlodipine and benazepril hydrochloride capsules, USP safely and effectively. See full prescribing information for amlodipine and benazepril hydrochloride capsules, USP. AMLODIPINE and BENAZEPRIL hydrochloride capsules, USP for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-09-2214000937370, 000937371, 000937372, 000937373, 000937670, 000937671
42e59a70d3-d9f2-43ea-92e7-271a2b2d4b1a (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-09-022681511364
43f12f18bb-7ddb-e7dc-4edd-32f4ac212bca (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. AMLODIPINE and BENAZEPRIL hydrochloride capsules USP, for oral use Initial U.S. Approval: 1995prescriptionHuman PrescriptionDr. Reddy'S Laboratories Ltdanalysis, manufacture2015-06-188551110586, 551110587
44f3817371-3b20-4437-8fdb-8e3dd95863ea (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride CapsulesInitial U.S. Approval: 1995prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-05-081001636294878
45f40161f0-7b9e-4131-92d6-893cb9473e71 (view SPL)These highlights do not include all the information needed to use Amlodipine Besylate and Benazepril Hydrochloride Capsules safely and effectively. See full prescribing information for Amlodipine Besylate and Benazepril Hydrochloride Capsules . A mlodipine B esylate and B enazepril H ydrochloride Capsules Initial U.S. Approval: 1995prescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-10-102681511365
46f7378a01-f825-4905-9134-6ff13cac10c9 (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride capsules safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride CapsulesInitial U.S. Approval: 1995prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-12-169498840929, 498840930, 498840931, 498840932, 498840952, 498840953
47fe4734a2-6219-8bf5-9c3a-d392910db4dc (view SPL)These highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules , USP Initial U.S. Approval: 1995prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-05-1316005913761, 005913762

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII