Details for New Drug Application (NDA): 206910

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NDA 206910 describes JADENU, which is a drug marketed by Novartis Pharms Corp and Novartis and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug and three Paragraph IV challenges. Additional details are available on the JADENU profile page.

The generic ingredient in JADENU is deferasirox. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the deferasirox profile page.

Summary for 206910

Tradename:	JADENU
Applicant:	Novartis Pharms Corp
Ingredient:	deferasirox
Patents:	1

Pharmacology for NDA: 206910

Mechanism of Action	Cytochrome P450 1A2 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A4 Inducers Iron Chelating Activity

Suppliers and Packaging for NDA: 206910

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JADENU	deferasirox	TABLET;ORAL	206910	NDA	Novartis Pharmaceuticals Corporation	0078-0654	0078-0654-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0654-15)
JADENU	deferasirox	TABLET;ORAL	206910	NDA	Novartis Pharmaceuticals Corporation	0078-0655	0078-0655-15	30 TABLET, FILM COATED in 1 BOTTLE (0078-0655-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	90MG
Approval Date:	Mar 30, 2015	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 21, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	180MG
Approval Date:	Mar 30, 2015	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 21, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	360MG
Approval Date:	Mar 30, 2015	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 21, 2034	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 206910

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-003	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-002	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
Novartis Pharms Corp	JADENU	deferasirox	TABLET;ORAL	206910-001	Mar 30, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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