Application 022083

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	4.6MG/24HR	Yes	No
002	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	9.5MG/24HR	Yes	Yes
005	EXELON	RIVASTIGMINE	FILM, EXTENDED RELEASE;TRANSDERMAL	13.3MG/24HR	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0501	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0502	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0503	Exelon	rivastigmine	Novartis Pharmaceuticals Corporation	NDA	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7304	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7309	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-7313	Rivastigmine	rivastigmine	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
21695-357	Exelon	rivastigmine	Rebel Distributors Corp	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78457	SUPPL	2024-05-14
78443	SUPPL	2024-05-09
56933	SUPPL	2018-12-21
56798	SUPPL	2018-12-19
45806	SUPPL	2016-11-04
45801	SUPPL	2016-11-03
45790	SUPPL	2016-11-02
29221	SUPPL	2015-02-05
16919	SUPPL	2015-02-05
38206	SUPPL	2013-07-11
6851	SUPPL	2013-07-01
16918	SUPPL	2012-09-06
6850	SUPPL	2012-09-05
16917	SUPPL	2010-09-07
6849	SUPPL	2010-08-31
42410	ORIG	2009-05-28
16916	ORIG	2007-07-09

Application 022083

Related Records#

Application Products#

NDC Listings For This Application#

Documents#