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. 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: | RX | Dosage: | CAPSULE;ORAL | Strength | 65MG | ||||
Approval Date: | Dec 11, 2018 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 21, 2033 | Product Flag? | Y | Substance 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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