Application 206910

Type: NDA
Sponsor: NOVARTIS PHARMS CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JADENU	DEFERASIROX	TABLET;ORAL	90MG	Yes	No
002	JADENU	DEFERASIROX	TABLET;ORAL	180MG	Yes	No
003	JADENU	DEFERASIROX	TABLET;ORAL	360MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0654	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0655	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0656	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80209	SUPPL	2024-11-14
80208	SUPPL	2024-11-14
64104	SUPPL	2020-07-27
64103	SUPPL	2020-07-27
64088	SUPPL	2020-07-27
59477	SUPPL	2019-07-29
59476	SUPPL	2019-07-29
59468	SUPPL	2019-07-26
58941	SUPPL	2019-06-04
58876	SUPPL	2019-05-29
56886	SUPPL	2018-12-20
56885	SUPPL	2018-12-20
56737	SUPPL	2018-12-14
56736	SUPPL	2018-12-14
55128	SUPPL	2018-08-07
55116	SUPPL	2018-08-06
54204	SUPPL	2018-05-16
54175	SUPPL	2018-05-14
52703	SUPPL	2018-02-23
52681	SUPPL	2018-02-22
52129	SUPPL	2018-01-30
52117	SUPPL	2018-01-30
45081	SUPPL	2016-08-17
45122	SUPPL	2016-08-12
46076	ORIG	2016-08-04
40572	SUPPL	2015-10-26
40571	SUPPL	2015-10-26
32833	SUPPL	2015-10-26
32832	SUPPL	2015-10-26
40570	ORIG	2015-04-07
10603	ORIG	2015-04-03

Application 206910

Related Records#

Application Products#

NDC Listings For This Application#

Documents#