Application 207968

Type: NDA
Sponsor: NOVARTIS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0713	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0720	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0727	Jadenu	deferasirox	Novartis Pharmaceuticals Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64102	SUPPL	2020-07-27
64101	SUPPL	2020-07-27
64089	SUPPL	2020-07-24
59475	SUPPL	2019-07-29
59474	SUPPL	2019-07-29
59464	SUPPL	2019-07-26
58942	SUPPL	2019-06-04
58875	SUPPL	2019-05-29
56888	SUPPL	2018-12-20
56887	SUPPL	2018-12-20
56735	SUPPL	2018-12-14
56734	SUPPL	2018-12-14
55129	SUPPL	2018-08-07
55119	SUPPL	2018-08-06
54205	SUPPL	2018-05-16
54174	SUPPL	2018-05-14
52702	SUPPL	2018-02-23
52682	SUPPL	2018-02-22
48817	ORIG	2017-06-23
48816	ORIG	2017-06-23
48464	ORIG	2017-05-19
48451	ORIG	2017-05-19

Application 207968

Related Records#

Application Products#

NDC Listings For This Application#

Documents#