Details for New Drug Application (NDA): 208901
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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: | 6 |
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 | 51862-462-08 | 8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-08) |
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: | See Plans and Pricing | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | Patent Expiration: | Jul 25, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? |
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