Application 020818

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;80MG	Yes	No
002	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;160MG	Yes	No
003	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;160MG	Yes	No
004	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;320MG	Yes	No
005	DIOVAN HCT	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;320MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0314	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0315	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0383	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0471	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0472	Diovan HCT	valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5948	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5949	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5950	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5951	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5952	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-820	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-838	Diovan HCT	valsartan and hydrochlorothiazide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
68258-6053	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6056	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6095	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
68258-6096	Valsartan and Hydrochlorothiazide	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current
68258-6972	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current
68258-6973	Diovan HCT	valsartan and hydrochlorothiazide	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64430	SUPPL	2020-08-27
64383	SUPPL	2020-08-24
59062	SUPPL	2019-06-13
59057	SUPPL	2019-06-13
35409	SUPPL	2015-07-30
35408	SUPPL	2014-09-26
25908	SUPPL	2014-09-26
13479	SUPPL	2014-06-03
3411	SUPPL	2014-06-03
35407	SUPPL	2014-03-19
25907	SUPPL	2014-03-19
13480	SUPPL	2014-03-19
3412	SUPPL	2014-03-19
25906	SUPPL	2012-10-09
35406	SUPPL	2012-10-05
35405	SUPPL	2012-07-30
25905	SUPPL	2012-07-30
25903	SUPPL	2012-02-17
13477	SUPPL	2012-02-17
25904	SUPPL	2012-01-23
13478	SUPPL	2012-01-23
23600	ORIG	2011-12-22
25902	SUPPL	2011-12-14
25900	SUPPL	2011-12-14
35404	SUPPL	2011-12-12
35402	SUPPL	2011-12-12
35403	SUPPL	2011-06-27
25901	SUPPL	2011-06-09
13476	SUPPL	2010-05-03
3410	SUPPL	2010-04-23
25899	SUPPL	2008-08-05
25898	SUPPL	2007-09-11
25897	SUPPL	2006-12-04
13475	SUPPL	2006-11-22
25896	SUPPL	2006-05-02
13474	SUPPL	2006-05-02
35401	SUPPL	2005-07-15
25895	SUPPL	2005-07-15
43564	SUPPL	2005-07-08
25894	SUPPL	2004-06-02
13473	ORIG	2004-06-02
3409	ORIG	2004-06-02
41720	ORIG	2003-08-08
41721	SUPPL	2003-07-08
25893	SUPPL	2002-01-17

Application 020818

Related Records#

Application Products#

NDC Listings For This Application#

Documents#