Details for New Drug Application (NDA): 021882

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NDA 021882 describes EXJADE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the EXJADE profile page.

The generic ingredient in EXJADE 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 021882

Tradename:	EXJADE
Applicant:	Novartis
Ingredient:	deferasirox
Patents:	0

Pharmacology for NDA: 021882

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

Suppliers and Packaging for NDA: 021882

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882	NDA	Novartis Pharmaceuticals Corporation	0078-0468	0078-0468-15	30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)
EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882	NDA	Novartis Pharmaceuticals Corporation	0078-0469	0078-0469-15	30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0469-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	125MG
Approval Date:	Nov 2, 2005	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	250MG
Approval Date:	Nov 2, 2005	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	500MG
Approval Date:	Nov 2, 2005	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021882

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-003	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-002	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
Novartis	EXJADE	deferasirox	TABLET, FOR SUSPENSION;ORAL	021882-001	Nov 2, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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