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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 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. Twenty-one suppliers are listed for this compound. Additional details are available on the itraconazole 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: | 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 | 51862-462-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60) |
| TOLSURA | itraconazole | CAPSULE;ORAL | 208901 | NDA | Mayne Pharma Inc. | 51862-462 | 51862-462-88 | 8 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 65MG | ||||
| Approval Date: | Dec 11, 2018 | TE: | RLD: | Yes | |||||
| Patent: | Get Started Free | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS | ||||||||
| Patent: | Get Started Free | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Get Started Free | Patent Expiration: | Jul 25, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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