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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 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. Eight suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for NDA: 020083

Tradename:
SPORANOX
Applicant:
Janssen Pharms
Ingredient:
itraconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 020083

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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,267,179► subscribe
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19925,633,015► subscribe
Janssen Pharms
SPORANOX
itraconazole
CAPSULE;ORAL020083-001Sep 11, 19924,791,111► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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