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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

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. Twenty-one 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
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 020657
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX SOLUTION;ORAL itraconazole 020657 2013-05-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Feb 21, 1997TE:AARLD:Yes

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

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Serving leading biopharmaceutical companies globally:

Merck
McKesson
Express Scripts
Johnson and Johnson
Medtronic
Colorcon

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