Medicine
Jublia 100 mg/mL topical solution
Jublia 100 mg/mL topical solution is a prescription medicine containing Efinaconazole for topical use, marketed by Bausch Health, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C…
Key facts
- Active ingredient (INN)
- Efinaconazole
- Brand
- Jublia
- Strength
- 100 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle
- Marketing authorisation holder
- Bausch Health
- Manufacturer
- Bausch Health
- Origin register
- US FDA, United States
- Storage
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). • Solution is flammable, keep away from heat or flame. • Protect from freezing. • Keep out of reach of children. • Keep bottle tightly closed. • Store in upright position.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AC19 Efinaconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 6 June 2014
- Identifiers
- RxCUI 1539757, 1539762DailyMed set ID 922d4d25-c530-11e1-9b21-0800200c9a66NDC 0187-5400Application NDA203567
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, with applicator in 1 carton / 2 mL in 1 bottle, with applicator | 0187-5400-02 | Bausch Health | 17 December 2015 |
| 1 bottle, with applicator in 1 carton / 4 mL in 1 bottle, with applicator | 0187-5400-04 | Bausch Health | 6 June 2014 |
| 1 bottle, with applicator in 1 carton / 8 mL in 1 bottle, with applicator | 0187-5400-08 | Bausch Health | 6 June 2014 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 6 June 2014 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Efinaconazole is an azole antifungal indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. It is available as topical solution. MedsAcross supplies Efinaconazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about EfinaconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- JUBLIA prescribing information (Bausch Health) · U.S. National Library of Medicine, DailyMed
Need Jublia 100 mg/mL topical solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.