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Generated: April 18, 2019

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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 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:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 29, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 3, 2028Product Flag?YSubstance 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 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Sign Up ➤ Sign Up
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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