Medicine
Ethyol 500 mg/10 mL injection
Ethyol 500 mg/10 mL injection is a prescription medicine containing Amifostine for intravenous use, marketed by Legacy Pharma, 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 the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Amifostine
- Brand
- Ethyol
- Strength
- 500 mg/10 mL
- Dosage form
- Injection
- Route
- Intravenous
- Packs
- 3 vials of 10 mL
- Marketing authorisation holder
- Legacy Pharma
- Manufacturer
- Legacy Pharma
- Origin register
- US FDA, United States
- Storage
- Store the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions permitted between 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
- V03AF05 Amifostine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 March 2026
- Identifiers
- RxCUI 308096, 1803018DailyMed set ID a17563f2-d231-4385-bc94-0217be78b89dNDC 83107-030Application NDA020221
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 |
|---|---|---|---|
| 3 vial, single-dose in 1 carton / 10 mL in 1 vial, single-dose | 83107-030-02 | Legacy Pharma | 16 March 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 8 December 1995 | 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
Amifostine is a cytoprotective agent indicated for – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer, among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Amifostine 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 AmifostineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Ethyol prescribing information (Legacy Pharma) · U.S. National Library of Medicine, DailyMed
Need Ethyol 500 mg/10 mL injection 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.