FLUDARABINE PHOSPHATE FOR INJECTION 25 MG
FLUDARABINE PHOSPHATE : 25 MG · DIN 02283859 · TEVA CANADA LIMITED
Health Canada status: MARKETED
What is FLUDARABINE PHOSPHATE FOR INJECTION?
FLUDARABINE PHOSPHATE FOR INJECTION 25 MG contains FLUDARABINE PHOSPHATE : 25 MG. It is listed in the Health Canada Drug Product Database under DIN 02283859, held by TEVA CANADA LIMITED, supplied as SOLUTION for INTRAVENOUS administration. Health Canada currently lists it as marketed, status dated 08-Feb-2014. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is FLUDARABINE PHOSPHATE FOR INJECTION used for?
FLUDARABINE PHOSPHATE FOR INJECTION (fludarabine phosphate) is indicated for: • Second-line treatment in patients with chronic lymphocytic leukemia (CLL) and low-grade non-Hodgkin's lymphoma (Lg-NHL) who have failed other conventional therapies.
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
Product details and regulatory record
| DIN | 02283859 |
|---|---|
| Brand name | FLUDARABINE PHOSPHATE FOR INJECTION |
| Generic / active ingredient | FLUDARABINE PHOSPHATE : 25 MG |
| Manufacturer | TEVA CANADA LIMITED |
| Strength | 25 MG |
| Dosage form | SOLUTION |
| Route of administration | INTRAVENOUS |
| Schedule | Prescription |
| ATC code | L01BB05 FLUDARABINE |
| AHFS class | 10:00.00 |
| Biosimilar | No |
| Health Canada status | MARKETED |
| Status date | 08-Feb-2014 |
| Original market date | 2006-12-04 00:00:00 |
How is it stored and handled?
Use within 24 hours when kept at room temperature and 72 hours when refrigerated.
How is it supplied?
2 mL single use vial containing 50 mg of fludarabine phosphate, 50 mg of mannitol, and 6.6 mg of sodium hydroxide. Packaged in a single vial carton.
Is FLUDARABINE in shortage in Canada?
A Canadian shortage report is on file for this molecule: Resolved — reported by ACCORD HEALTHCARE INC, last seen 04 Sep 2026. A shortage on one presentation does not always affect every DIN of the molecule — the alternatives below list what else is marketed in Canada. Nexara can confirm current availability and identify substitutions or import options where permitted.
What can be used instead?
Other Canadian products sharing ATC code L01BB05 FLUDARABINE. 3 of 10 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.
| Product | Strength | Form | Manufacturer | Health Canada status | DIN |
|---|---|---|---|---|---|
| FLUDARA | 10 MG | TABLET | SANOFI-AVENTIS CANADA INC | MARKETED | DIN 02246226 |
| FLUDARABINE PHOSPHATE INJECTION, USP | 25 MG | SOLUTION | ACCORD HEALTHCARE INC | MARKETED | DIN 02438577 |
| AJ-FLUDARABINE | 25.0 MG | SOLUTION | AGILA JAMP CANADA INC | CANCELLED PRE MARKET | DIN 02409046 |
| FLUDARA | 50 MG | POWDER FOR SOLUTION | SANOFI GENZYME, A DIVISION OF SANOFI-AVENTIS CANADA INC | CANCELLED POST MARKET | DIN 01989537 |
| FLUDARABINE PHOSPHATE FOR INJECTION | 50 MG | POWDER FOR SOLUTION | FRESENIUS KABI CANADA LTD | CANCELLED PRE MARKET | DIN 02351730 |
| FLUDARABINE PHOSPHATE FOR INJECTION USP | 50 MG | POWDER FOR SOLUTION | HOSPIRA HEALTHCARE ULC | CANCELLED POST MARKET | DIN 02293846 |
| FLUDARABINE PHOSPHATE INJECTION | 25 MG | SOLUTION | MYLAN PHARMACEUTICALS ULC | CANCELLED PRE MARKET | DIN 02406381 |
| FLUDARABINE PHOSPHATE INJECTION | 25 MG | SOLUTION | FRESENIUS KABI CANADA LTD | DORMANT | DIN 02351722 |
| FLUDARABINE PHOSPHATE INJECTION | 25 MG | LIQUID | OMEGA LABORATORIES LIMITED | APPROVED | DIN 02416069 |
Who else supplies FLUDARABINE worldwide?
Nexara tracks national medicine registries and published price lists across multiple markets. FLUDARABINE appears in 25 registered pack listings across 7 markets, published on 6 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.
Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.