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. 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.

Summary for 022484

Tradename:	ONMEL
Applicant:	Sebela Ireland Ltd
Ingredient:	itraconazole
Patents:	1
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 022484

14-alpha Demethylase Inhibitors
Antifungal Agents
Cytochrome P-450 CYP3A Inhibitors

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

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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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