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Details for New Drug Application (NDA): 022484
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NDA 022484 describes ONMEL, which is a drug marketed by Sebela Ireland Ltd and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ONMEL profile page.
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.
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 |
Suppliers and Packaging for NDA: 022484
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONMEL | itraconazole | TABLET;ORAL | 022484 | NDA | Merz Pharmaceuticals, LLC | 0259-1420 | 0259-1420-28 | 2 BLISTER PACK in 1 CARTON (0259-1420-28) > 14 TABLET in 1 BLISTER PACK (0259-1420-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Apr 29, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | 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 | Start Trial | Start Trial |
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | Start Trial | Start Trial |
| Sebela Ireland Ltd | ONMEL | itraconazole | TABLET;ORAL | 022484-001 | Apr 29, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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