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Jublia FDA Approval History

FDA Approved: Yes (First approved June 6, 2014)
Brand name: Jublia
Generic name: efinaconazole
Dosage form: Topical Solution
Company: Bausch Health Companies Inc.
Treatment for: Onychomycosis, Toenail

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

Jublia (efinaconazole) is a topical triazole antifungal for the treatment of onychomycosis of the toenails.

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Development timeline for Jublia

DateArticle
Apr 29, 2020Approval FDA Approves Ortho Dermatologics' Labeling for Jublia (efinaconazole) Topical Solution, 10%, In Patients As Young As Six Years Old
Jun  9, 2014Approval Valeant Pharmaceuticals Announces FDA Approval Of Jublia for the Treatment of Onychomycosis
May 28, 2013Valeant Pharmaceuticals Announces Receipt Of U.S. FDA Complete Response Letter For Efinaconazole

See also

Jublia (efinaconazole) Consumer information

Further information

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