Active substance
Efinaconazole
- US FDA 8
- Health Canada 1
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| JUBLIA | 10% | solution · topical | BAUSCH | Prescription | 6 Jun 2014 |
| EFINACONAZOLE | 10% | solution · topical | TEVA PHARMS USA | Prescription | 16 Dec 2020 |
| EFINACONAZOLE | 10% | solution · topical | NIVAGEN PHARMS INC | Prescription | 21 Jun 2021 |
| EFINACONAZOLE | 10% | solution · topical | PADAGIS US | Discontinued | 16 Dec 2020 |
| EFINACONAZOLE | 10% | solution · topical | AUROBINDO PHARMA LTD | Discontinued | 29 Mar 2021 |
| EFINACONAZOLE | 10% | solution · topical | LUPIN | Discontinued | 2 Mar 2022 |
| EFINACONAZOLE | 10% | solution · topical | ZYDUS LIFESCIENCES | Discontinued | 15 Jul 2022 |
| EFINACONAZOLE | 10% | solution · topical | ALEMBIC | Discontinued | 23 Feb 2026 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| JUBLIA | 02413388 | 10 % / W/W | SOLUTION · TOPICAL | BAUSCH HEALTH, CANADA INC. |
Safety signals and safety-related labeling changes
- US FDA 31 Mar 2022 JUBLIA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.