Application 209884

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAYZENT	SIPONIMOD FUMARIC ACID	TABLET;ORAL	EQ 0.25MG BASE	Yes	No
002	MAYZENT	SIPONIMOD FUMARIC ACID	TABLET;ORAL	EQ 2MG BASE	Yes	Yes
003	MAYZENT	SIPONIMOD FUMARIC ACID	TABLET;ORAL	EQ 1MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0979	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0986	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1014	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1014	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current
0078-1014	MAYZENT	siponimod	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83193	SUPPL	2025-08-26
83191	SUPPL	2025-08-26
83168	SUPPL	2025-08-22
78725	SUPPL	2024-07-02
78689	SUPPL	2024-06-06
75052	SUPPL	2023-08-14
75051	SUPPL	2023-08-14
75045	SUPPL	2023-08-11
73357	SUPPL	2023-02-01
73354	SUPPL	2023-02-01
71464	SUPPL	2022-06-28
71456	SUPPL	2022-06-27
71424	SUPPL	2022-06-22
71310	SUPPL	2022-06-15
71309	SUPPL	2022-06-15
71304	SUPPL	2022-06-14
70371	SUPPL	2022-03-02
70370	SUPPL	2022-03-02
70357	SUPPL	2022-03-02
69009	SUPPL	2021-10-15
68616	SUPPL	2021-09-14
68456	SUPPL	2021-08-25
65998	SUPPL	2021-01-26
65997	SUPPL	2021-01-26
65991	SUPPL	2021-01-26
64499	SUPPL	2020-09-04
64488	SUPPL	2020-09-03
64159	SUPPL	2020-07-31
58550	ORIG	2019-05-03
58094	ORIG	2019-03-27
58080	ORIG	2019-03-27
58079	ORIG	2019-03-27

Application 209884

Related Records#

Application Products#

NDC Listings For This Application#

Documents#