Medicine
Tavaborole 43.5 mg/mL topical solution
Tavaborole 43.5 mg/mL topical solution is a generic prescription medicine for topical use, made by 6 labelers, 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° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Tavaborole
- Brand
- Sold under the generic name
- Strength
- 43.5 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 10 mL and 5 more
- Manufacturers
- Alembic PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaChartwell RXEncube Ethicals6 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D01AE24 Tavaborole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 19 October 2020
- Identifiers
- RxCUI 1543177DailyMed set ID 22a6617b-d4b1-405e-901a-0b39a7b2837d, 7ad9dc39-7501-4db5-a935-d9be8eea30a6, 050f5d10-5591-426e-9020-6516b3363304 +4NDC 62332-467, 51862-690, 21922-020 +4Application ANDA212188, ANDA211297, ANDA211963 +1
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
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 4 mL in 1 bottle, dropper | 46708-467-04 | Alembic PharmaceuticalsIndia | 18 February 2025 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 46708-467-10 | Alembic PharmaceuticalsIndia | 18 February 2025 |
| 1 bottle, dropper in 1 carton / 4 mL in 1 bottle, dropper | 62332-467-04 | Alembic PharmaceuticalsIndia | 23 October 2020 |
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 62332-467-10 | Alembic PharmaceuticalsIndia | 23 October 2020 |
| 1 bottle, with applicator in 1 carton / 10 mL in 1 bottle, with applicator | 72578-102-04 | Viona PharmaceuticalsIndia | 24 April 2023 |
| 1 bottle, with applicator in 1 carton / 10 mL in 1 bottle, with applicator | 70771-1826-0 | Zydus LifesciencesIndia | 24 April 2023 |
| 10 mL in 1 bottle, dropper | 62135-663-59 | Chartwell RX | 8 September 2023 |
| 1 bottle, with applicator in 1 carton / 10 mL in 1 bottle, with applicator | 21922-020-12 | Encube Ethicals | 19 October 2020 |
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 7 July 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
Tavaborole is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophyte. It is available as topical solution. MedsAcross supplies Tavaborole 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 TavaboroleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Tavaborole prescribing information (Encube Ethicals) · U.S. National Library of Medicine, DailyMed
Need Tavaborole 43.5 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.