FDA — authorised 6 June 2014
- Marketing authorisation holder: DOW PHARM
- Status: approved
🇺🇸 Jublia in United States
FDA authorised Jublia on 6 June 2014
Marketing authorisations
FDA — authorised 5 November 2015
- Application: NDA203567
- Marketing authorisation holder: BAUSCH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA211851
- Marketing authorisation holder: PADAGIS US
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 16 December 2020
- Application: ANDA211827
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 29 March 2021
- Application: ANDA212066
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 March 2022
- Application: ANDA212169
- Marketing authorisation holder: LUPIN
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 15 July 2022
- Application: ANDA212178
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 23 February 2026
- Application: ANDA212027
- Marketing authorisation holder: ALEMBIC
- Local brand name: EFINACONAZOLE
- Indication: SOLUTION — TOPICAL
- Status: approved
The FDA approved Jublia (efinaconazole) topical solution for the treatment of onychomycosis of the toenails. This approval was granted to Alembic under the standard expedited pathway. The application number for this approval is ANDA212027.
Jublia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Jublia approved in United States?
Yes. FDA authorised it on 6 June 2014; FDA authorised it on 5 November 2015; FDA authorised it on 16 December 2020.
Who is the marketing authorisation holder for Jublia in United States?
DOW PHARM holds the US marketing authorisation.