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Generated: January 16, 2019

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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 four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 020657
Medical Subject Heading (MeSH) Categories for 020657
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:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Feb 21, 1997TE:AARLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 18, 2019Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 020657

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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Serving hundreds of leading biopharmaceutical companies globally:

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Johnson and Johnson
US Department of Justice
Julphar
Cerilliant
Fuji
Argus Health
Accenture
McKesson

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