Details for New Drug Application (NDA): 022484
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The generic ingredient in ONMEL 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 022484
Tradename: | ONMEL |
Applicant: | Sebela Ireland Ltd |
Ingredient: | itraconazole |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 022484
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Apr 29, 2010 | TE: | RLD: | Yes | |||||
Patent: | See Plans and Pricing | Patent Expiration: | Oct 3, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS |
Expired US Patents for NDA 022484
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | See Plans and Pricing | See Plans and Pricing |
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | See Plans and Pricing | See Plans and Pricing |
Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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