Details for New Drug Application (NDA): 020657

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NDA 020657 describes SPORANOX, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from two 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. Fourteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 020657

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

Medical Subject Heading (MeSH) Categories for 020657

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Feb 21, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020657

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Get Started Free	⤷ Get Started Free
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Get Started Free	⤷ Get Started Free
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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