Medicine
Arava 10 mg tablet
Arava 10 mg tablet is a prescription medicine containing Leflunomide for oral use, marketed by Sanofi-Aventis, 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 to 15°C to 30°C (59°F to 86°F)…
Key facts
- Active ingredient (INN)
- Leflunomide
- Brand
- Arava
- Strength
- 10 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Sanofi-Aventis
- Manufacturer
- Sanofi-Aventis
- Origin register
- US FDA, United States
- Storage
- Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- L04AK01 Leflunomide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 10 September 1998
- Identifiers
- RxCUI 205284, 205285, 205286 +3DailyMed set ID 320f63f2-fac3-4aee-aff8-85724e00ef52NDC 0088-2160Application NDA020905
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 in 1 carton / 30 tablet, film coated in 1 bottle | 0088-2160-30 | sanofi-aventis | 19 September 1998 |
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.
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
Alternatives
Other makers and brands of Leflunomide 10 mg tablet.
Other strengths and forms of Leflunomide
Clinical summary
Leflunomide is an antirheumatic agent indicated for the treatment of adults with active rheumatoid arthritis (RA). It is available as tablets for oral use. MedsAcross supplies Leflunomide 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 LeflunomideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Arava prescribing information (sanofi-aventis) · U.S. National Library of Medicine, DailyMed
- Arava: European public assessment report (EPAR) · European Medicines Agency
- Leflunomide Zentiva (previously Leflunomide Winthrop): European public assessment report (EPAR) · European Medicines Agency
Need Arava 10 mg tablet 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.