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Details for New Drug Application (NDA): 203567

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NDA 203567 describes JUBLIA, which is a drug marketed by Dow Pharm 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 JUBLIA profile page.

The generic ingredient in JUBLIA is efinaconazole. There are four 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 NDA: 203567

Tradename:
JUBLIA
Applicant:
Dow Pharm
Ingredient:
efinaconazole
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 203567

Ingredient-typeAzoles

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 Valeant Pharmaceuticals North America 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 Valeant Pharmaceuticals North America LLC 0187-5400 0187-5400-04 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0187-5400-04) > 4 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength10%
Approval Date:Jun 6, 2014TE:RLD:Yes
Patent:8,486,978Patent Expiration:Oct 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:9,302,009Patent Expiration:Oct 24, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:7,214,506Patent Expiration:Oct 5, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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