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Last Updated: June 5, 2020

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Details for New Drug Application (NDA): 208901


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NDA 208901 describes TOLSURA, which is a drug marketed by Mayne Pharma Intl and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the TOLSURA profile page.

The generic ingredient in TOLSURA 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 208901
Tradename:TOLSURA
Applicant:Mayne Pharma Intl
Ingredient:itraconazole
Patents:5
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208901
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOLSURA itraconazole CAPSULE;ORAL 208901 NDA Mayne Pharma Inc. 51862-462 51862-462-60 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength65MG
Approval Date:Dec 11, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 21, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Patent:  Start TrialPatent Expiration:Jul 25, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 21, 2033Product Flag?YSubstance Flag?Delist Request?

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