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Last Updated: September 26, 2023

Details for New Drug Application (NDA): 208901

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NDA 208901 describes TOLSURA, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There are six 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. Nineteen suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for 208901

Tradename:	TOLSURA
Applicant:	Mayne Pharma
Ingredient:	itraconazole
Patents:	6
Formulation / Manufacturing:	see details

Pharmacology for NDA: 208901

Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein 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 Commercial LLC	51862-462	51862-462-08	8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-08)
TOLSURA	itraconazole	CAPSULE;ORAL	208901	NDA	Mayne Pharma Commercial LLC	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:	⤷ Try a Trial	Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Patent:	⤷ Try a Trial	Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 25, 2023	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208901

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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