Details for New Drug Application (NDA): 020657

✉ Email this page to a colleague

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. Nineteen 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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Subscribe	⤷ Subscribe
Janssen Pharms	SPORANOX	itraconazole	SOLUTION;ORAL	020657-001	Feb 21, 1997	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.