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Last Updated: June 7, 2020

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Details for New Drug Application (NDA): 020966


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NDA 020966 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 020966
Tradename:SPORANOX
Applicant:Janssen Pharms
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020966

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Mar 30, 1999TE:RLD:No

Expired US Patents for NDA 020966

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole INJECTABLE;INJECTION 020966-001 Mar 30, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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