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Last Updated: April 22, 2024

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. 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 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 Janssen Pharmaceuticals, Inc. 50458-290 50458-290-01 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK

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

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