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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 203567


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NDA 203567 describes JUBLIA, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the JUBLIA profile page.

The generic ingredient in JUBLIA is efinaconazole. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efinaconazole profile page.
Summary for 203567
Tradename:JUBLIA
Applicant:Bausch
Ingredient:efinaconazole
Patents:18
Formulation / Manufacturing:see details
Pharmacology for NDA: 203567
Suppliers and Packaging for NDA: 203567
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JUBLIA efinaconazole SOLUTION;TOPICAL 203567 NDA Bausch Health US LLC 0187-5400 0187-5400-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-02) / 2 mL in 1 BOTTLE, WITH APPLICATOR
JUBLIA efinaconazole SOLUTION;TOPICAL 203567 NDA Bausch Health US LLC 0187-5400 0187-5400-04 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) / 4 mL in 1 BOTTLE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength10%
Approval Date:Jun 6, 2014TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jul 8, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 2, 2034Product Flag?YSubstance Flag?Delist Request?
Patented Use:ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES
Patent:⤷  Sign UpPatent Expiration:Apr 25, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF TINEA UNGUIUM BY USING AN APPLICATOR FOR APPLYING A SOLUTION FOR TREATING TINEA UNGUIUM TO AN AFFECTED PART OF A PATIENT

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