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Last Updated: March 28, 2024

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. Nineteen 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:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Apr 29, 2010TE:RLD:Yes
Patent:⤷  Try a TrialPatent 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 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try a Trial ⤷  Try a Trial
Sebela Ireland Ltd ONMEL itraconazole TABLET;ORAL 022484-001 Apr 29, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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