Application 020364

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 2.5MG BASE;10MG	Yes	No
003	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;10MG	Yes	No
004	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;20MG	Yes	No
005	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;20MG	Yes	No
006	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE;40MG	Yes	Yes
007	LOTREL	AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE	CAPSULE;ORAL	EQ 5MG BASE;40MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0364	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0379	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0384	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0404	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0405	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0406	Lotrel	amlodipine besylate and benazepril hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0615-1397	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-1398	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-1399	amlodipine besylate and benazepril hydrochloride	amlodipine besylate and benazepril hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0781-2271	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2272	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2273	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2274	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2277	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-2279	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
43063-233	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-039	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-096	Lotrel	amlodipine besylate and benazepril hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68151-1363	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68151-1365	Amlodipine Besylate and Benazepril Hydrochloride	amlodipine besylate and benazepril hydrochloride	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67881	SUPPL	2021-06-24
67138	SUPPL	2021-04-22
61861	SUPPL	2020-02-11
61859	SUPPL	2020-02-11
49072	SUPPL	2017-07-25
49050	SUPPL	2017-07-25
34560	SUPPL	2015-05-21
24854	SUPPL	2015-05-19
12490	SUPPL	2015-04-24
24853	SUPPL	2015-04-23
34559	SUPPL	2015-01-05
24852	SUPPL	2014-12-30
24851	SUPPL	2012-10-10
2396	SUPPL	2012-10-10
34558	SUPPL	2012-10-09
12489	SUPPL	2012-10-09
34557	SUPPL	2012-01-23
24850	SUPPL	2012-01-23
12488	SUPPL	2011-11-01
2395	SUPPL	2011-10-31
34556	SUPPL	2011-07-07
24849	SUPPL	2011-06-29
24848	SUPPL	2011-01-07
12487	SUPPL	2011-01-05
34554	SUPPL	2010-04-04
24847	SUPPL	2010-04-02
2394	SUPPL	2010-01-05
34555	SUPPL	2010-01-04
24846	SUPPL	2009-11-19
12486	SUPPL	2009-10-30
24845	SUPPL	2007-09-06
12485	SUPPL	2007-09-04
2393	SUPPL	2007-03-06
24843	SUPPL	2006-04-13
12483	SUPPL	2006-04-12
2392	SUPPL	2004-08-12
12484	SUPPL	2004-07-07
24844	SUPPL	2004-07-06
2391	SUPPL	2003-09-09
20611	SUPPL	2002-11-22
24842	SUPPL	2002-06-20
12482	SUPPL	2002-06-20
41302	SUPPL	2001-08-21
34553	SUPPL	1999-06-16
24841	SUPPL	1999-06-16
41301	SUPPL	1997-03-14

Application 020364

Related Records#

Application Products#

NDC Listings For This Application#

Documents#