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Last Updated: November 7, 2024

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 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. Eighteen 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
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:RXDosage:CAPSULE;ORALStrength65MG
Approval Date:Dec 11, 2018TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 21, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
Patent:⤷  Sign UpPatent Expiration:Jun 21, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Jun 21, 2033Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 208901

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

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