Medicine
Xtoro 3 mg/mL otic suspension
Xtoro 3 mg/mL otic suspension is a prescription medicine containing Finafloxacin for otic use, marketed by Fonseca Biosciences, 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
Do not freeze. Store at 2°C to 25°C (36°F to 77°F).
Key facts
- Active ingredient (INN)
- Finafloxacin
- Brand
- Xtoro
- Strength
- 3 mg/mL
- Dosage form
- Otic suspension
- Route
- Otic
- Packs
- 1 bottle
- Marketing authorisation holder
- Fonseca Biosciences
- Manufacturer
- Fonseca Biosciences
- Origin register
- US FDA, United States
- Storage
- Do not freeze. Store at 2°C to 25°C (36°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.20Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 May 2026
- Identifiers
- RxCUI 1598645, 1598650DailyMed set ID 5c628272-019e-4511-8d5c-dcf56023da25NDC 83709-001Application NDA206307
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, dropper in 1 carton / 5 mL in 1 bottle, dropper | 83709-001-01 | Fonseca Biosciences | 1 May 2026 |
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 17 December 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
Finafloxacin is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. MedsAcross supplies Finafloxacin 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 FinafloxacinFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XTORO prescribing information (Fonseca Biosciences) · U.S. National Library of Medicine, DailyMed
Need Xtoro 3 mg/mL otic suspension 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.