Application 021990

Type: NDA
Sponsor: NOVARTIS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0488	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0489	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0490	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0491	Exforge	amlodipine besylate and valsartan	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5615	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5628	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5639	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5643	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
50090-2471	AMLODIPINE AND VALSARTAN	amlodipine besylate and valsartan	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73304	SUPPL	2023-01-27
67008	SUPPL	2021-04-08
59064	SUPPL	2019-06-13
59059	SUPPL	2019-06-13
48427	SUPPL	2017-05-17
16702	SUPPL	2015-07-30
6606	SUPPL	2015-07-30
16701	SUPPL	2014-09-26
6605	SUPPL	2014-09-25
38011	SUPPL	2014-03-19
28992	SUPPL	2014-03-19
6604	SUPPL	2014-03-19
16700	SUPPL	2012-12-10
28991	SUPPL	2012-11-29
28990	SUPPL	2012-10-02
38010	SUPPL	2012-10-01
38009	SUPPL	2012-01-30
6603	SUPPL	2012-01-20
28989	SUPPL	2011-12-14
16699	SUPPL	2011-12-13
6602	SUPPL	2011-11-02
38008	SUPPL	2011-10-31
16698	SUPPL	2011-06-07
28988	SUPPL	2011-06-03
6601	SUPPL	2010-04-05
38007	SUPPL	2010-04-04
42370	ORIG	2008-10-03
6600	SUPPL	2008-07-25
38006	SUPPL	2008-07-24
6599	ORIG	2007-07-05
38005	ORIG	2007-06-25
6598	ORIG	2007-01-08

Application 021990

Related Records#

Application Products#

NDC Listings For This Application#

Documents#