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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020083

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NDA 020083 describes SPORANOX, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from three 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. Twenty suppliers are listed for this compound. Additional details are available on the itraconazole profile page.
Summary for 020083
Tradename:SPORANOX
Applicant:Janssen Pharms
Ingredient:itraconazole
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPORANOX itraconazole CAPSULE;ORAL 020083 NDA Patriot Pharmaceuticals 10147-1700 10147-1700-3 30 CAPSULE in 1 BOTTLE (10147-1700-3)
SPORANOX itraconazole CAPSULE;ORAL 020083 NDA Patriot Pharmaceuticals 10147-1700 10147-1700-7 7 POUCH in 1 DOSE PACK (10147-1700-7) > 1 BLISTER PACK in 1 POUCH > 4 CAPSULE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 020083
Tradename Dosage Ingredient NDA Submissiondate
SPORANOX CAPSULE;ORAL itraconazole 020083

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 11, 1992TE:ABRLD:Yes

Expired US Patents for NDA 020083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
Janssen Pharms SPORANOX itraconazole CAPSULE;ORAL 020083-001 Sep 11, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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