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 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. Eighteen 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

Pharmacology for NDA: 020657

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

Medical Subject Heading (MeSH) Categories for 020657

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

Suppliers and Packaging for NDA: 020657

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SPORANOX	itraconazole	SOLUTION;ORAL	020657	NDA	Patriot Pharmaceuticals, LLC	10147-0150	10147-0150-1	150 mL in 1 BOTTLE (10147-0150-1)
SPORANOX	itraconazole	SOLUTION;ORAL	020657	NDA	Janssen Pharmaceuticals, Inc.	50458-295	50458-295-15	150 mL in 1 BOTTLE (50458-295-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Feb 21, 1997	TE:	AA	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	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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