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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 020083

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NDA 020083 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 020083

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

Pharmacology for NDA: 020083

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for 020083

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

Suppliers and Packaging for NDA: 020083

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPORANOX	itraconazole	CAPSULE;ORAL	020083	NDA	Patriot Pharmaceuticals	10147-1700	10147-1700-3	30 CAPSULE in 1 BOTTLE (10147-1700-3)
SPORANOX	itraconazole	CAPSULE;ORAL	020083	NDA	Janssen Pharmaceuticals, Inc.	50458-290	50458-290-01	3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Sep 11, 1992	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020083

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	4,267,179	⤷ Get Started Free
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	5,633,015	⤷ Get Started Free
Janssen Pharms	SPORANOX	itraconazole	CAPSULE;ORAL	020083-001	Sep 11, 1992	4,791,111	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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