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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 Merz Pharms and is included in one NDA. It is available from one supplier. There are four patents 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. Eight suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for NDA: 022484

Tradename:
ONMEL
Applicant:
Merz Pharms
Ingredient:
itraconazole
Patents:4
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 022484

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Apr 29, 2010TE:RLD:Yes
Patent:6,509,038Patent Expiration:May 12, 2017Product 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
Patent:7,081,255Patent Expiration:May 12, 2017Product 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
Patent:8,486,456Patent 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


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