Medicine
Tolsura 65 mg capsule
Tolsura 65 mg capsule is a prescription medicine containing Itraconazole for oral use, marketed by Mayne Pharma Commercial, 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 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F).
Key facts
- Active ingredient (INN)
- Itraconazole
- Brand
- Tolsura
- Strength
- 65 mg
- Dosage form
- Capsule
- Route
- Oral
- Packs
- 60 capsules
- Marketing authorisation holder
- Mayne Pharma Commercial
- Manufacturer
- Mayne Pharma Commercial
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- J02AC02 Itraconazole
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 11 December 2018
- Identifiers
- RxCUI 2106642, 2106648DailyMed set ID 306352d1-9d5a-49ad-b72d-893b99546861NDC 51862-462Application NDA208901
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 |
|---|---|---|---|
| 60 capsule, gelatin coated in 1 bottle, plastic | 51862-462-60 | Mayne Pharma Commercial | 11 December 2018 |
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 11 September 1992 | 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
Other strengths and forms of Itraconazole
Clinical summary
Itraconazole is an azole antifungal indicated for the treatment of fungal infections in immunocompromised and non-immunocompromised patients. It is available as capsules and oral solution. MedsAcross supplies Itraconazole 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 ItraconazoleFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- SPORANOX prescribing information (Janssen Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Tolsura 65 mg capsule 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.