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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

Pharmacology for NDA: 208901

Mechanism of Action

Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors

Medical Subject Heading (MeSH) Categories for 208901

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP3A Inhibitors

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:	RX	Dosage:	CAPSULE;ORAL			Strength	65MG
Approval Date:	Dec 11, 2018	TE:		RLD:	Yes
Patent:		Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Patent:		Patent Expiration:	Jul 25, 2023	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

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