Application 022314

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	Yes	No
002	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	Yes	No
003	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	Yes	No
004	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	Yes	No
005	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5756	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5760	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5771	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5787	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5794	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72400	SUPPL	2022-10-17
72311	SUPPL	2022-10-12
67995	SUPPL	2021-06-30
66321	SUPPL	2021-02-23
64380	SUPPL	2020-08-24
64336	SUPPL	2020-08-20
59063	SUPPL	2019-06-13
59060	SUPPL	2019-06-13
17233	SUPPL	2015-07-30
7222	SUPPL	2015-07-30
38560	SUPPL	2014-09-26
29582	SUPPL	2014-09-25
38559	SUPPL	2014-06-10
38558	SUPPL	2014-03-19
38557	SUPPL	2014-03-19
29581	SUPPL	2014-03-19
7221	SUPPL	2014-03-19
17232	SUPPL	2012-12-10
29580	SUPPL	2012-11-29
29579	SUPPL	2012-10-02
17231	SUPPL	2012-10-01
29576	SUPPL	2012-02-21
17229	SUPPL	2012-02-17
29578	SUPPL	2012-01-20
7220	SUPPL	2011-12-14
38556	SUPPL	2011-12-13
29577	SUPPL	2011-11-02
17230	SUPPL	2011-10-31
17228	SUPPL	2011-06-27
29575	SUPPL	2011-06-13
42489	ORIG	2009-09-02
24280	ORIG	2009-09-02
29574	ORIG	2009-05-14
17227	ORIG	2009-05-11

Application 022314

Related Records#

Application Products#

NDC Listings For This Application#

Documents#