Details for New Drug Application (NDA): 203567
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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: | 16 |
Formulation / Manufacturing: | see details |
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: | RX | Dosage: | SOLUTION;TOPICAL | Strength | 10% | ||||
Approval Date: | Jun 6, 2014 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Apr 27, 2023 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Patent: | See Plans and Pricing | Patent Expiration: | Jul 8, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | See Plans and Pricing | Patent Expiration: | Oct 2, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES |
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