Details for New Drug Application (NDA): 020966

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NDA 020966 describes SPORANOX, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from three suppliers. Additional details are available on the SPORANOX profile page.

The generic ingredient in SPORANOX is itraconazole. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 020966

Tradename:	SPORANOX
Applicant:	Janssen Pharms
Ingredient:	itraconazole
Patents:	0

Medical Subject Heading (MeSH) Categories for 020966

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Mar 30, 1999	TE:		RLD:	No

Expired US Patents for NDA 020966

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	SPORANOX	itraconazole	INJECTABLE;INJECTION	020966-001	Mar 30, 1999	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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