Application 021283

Type: NDA
Sponsor: NOVARTIS

Related Records

Company: NOVARTIS

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIOVAN	VALSARTAN	TABLET;ORAL	80MG	Yes	No
002	DIOVAN	VALSARTAN	TABLET;ORAL	160MG	Yes	No
003	DIOVAN	VALSARTAN	TABLET;ORAL	320MG	Yes	Yes
004	DIOVAN	VALSARTAN	TABLET;ORAL	40MG	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0358	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0359	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0360	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0423	Diovan	valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5607	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5608	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5618	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5619	Valsartan	valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-917	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
21695-918	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
21695-919	Diovan	valsartan	Rebel Distributors Corp	NDA	Current
43353-059	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-066	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-067	Valsartan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-817	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-825	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-876	Diovan	valsartan	PD-Rx Pharmaceuticals, Inc.	NDA	Current
63629-6922	Valsartan	valsartan	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-6922	Valsartan	valsartan	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
67544-403	Diovan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
67544-404	Diovan	valsartan	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68151-4349	Diovan	valsartan	Carilion Materials Management	NDA	Current
68151-5044	Diovan	valsartan	Carilion Materials Management	NDA	Current

Documents

Document	Submission type	Date
85886	SUPPL	2026-05-12
85881	SUPPL	2026-05-12
68560	SUPPL	2021-09-08
68554	SUPPL	2021-09-08
67132	SUPPL	2021-04-22
67124	SUPPL	2021-04-20
59061	SUPPL	2019-06-13
59058	SUPPL	2019-06-13
47126	SUPPL	2017-02-07
47106	SUPPL	2017-02-06
14870	SUPPL	2015-07-30
4898	SUPPL	2015-07-28
4897	SUPPL	2014-10-01
36571	SUPPL	2014-09-30
27365	SUPPL	2014-03-19
14869	SUPPL	2014-03-19
14868	SUPPL	2014-03-19
4896	SUPPL	2014-03-19
4895	SUPPL	2012-10-09
36570	SUPPL	2012-10-05
27364	SUPPL	2012-07-30
14867	SUPPL	2012-07-30
36568	SUPPL	2012-03-06
42079	SUPPL	2012-03-02
42078	SUPPL	2012-03-02
4894	SUPPL	2012-02-29
36569	SUPPL	2012-01-23
27363	SUPPL	2012-01-23
44113	ORIG	2011-12-22
4893	SUPPL	2011-12-14
14866	SUPPL	2011-12-12
36567	SUPPL	2011-06-07
27362	SUPPL	2011-06-07
36566	SUPPL	2009-06-22
4892	SUPPL	2009-06-17
4891	SUPPL	2008-01-09
36565	SUPPL	2007-12-03
4890	SUPPL	2007-08-22
21573	ORIG	2007-06-22
42077	SUPPL	2007-03-31
27361	SUPPL	2006-12-04
14865	SUPPL	2006-12-04
42076	SUPPL	2006-06-06
36563	SUPPL	2006-06-06
27360	SUPPL	2005-08-08
14864	SUPPL	2005-08-08
4889	SUPPL	2004-12-06
36564	SUPPL	2004-12-03
14862	ORIG	2003-05-05
42075	SUPPL	2002-08-14
36562	SUPPL	2002-08-14
4888	SUPPL	2002-08-14
27359	SUPPL	2002-04-05
21574	SUPPL	2002-04-05
14863	SUPPL	2002-04-05
53436	ORIG	1900-01-01
53435	ORIG	1900-01-01
53434	ORIG	1900-01-01