Details for New Drug Application (NDA): 208901

✉ Email this page to a colleague

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 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. 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:	5

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	51862-462-60	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:	⤷ Subscribe	Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Patent:	⤷ Subscribe	Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Jun 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208901

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mayne Pharma	TOLSURA	itraconazole	CAPSULE;ORAL	208901-001	Dec 11, 2018	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.