Quick answers
- What is Fludarabine phosphate used for?
- The FDA-approved label (Fludarabine, Fresenius Kabi USA, LLC, October 14, 2024) says: “Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fludarabine phosphate have a boxed warning?
- Yes. The FDA label for Fludarabine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Fludarabine phosphate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fludarabine phosphate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Fludarabine phosphate?
- 6 companies list prescription products of Fludarabine phosphate in the FDA NDC Directory, including Areva Pharmaceuticals, Fresenius Kabi USA, LLC and Sagent Pharmaceuticals.
What Fludarabine phosphate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. …
— FDA label: Fludarabine, Fresenius Kabi USA, LLC, effective October 14, 2024. Read the full label on DailyMed →
The FDA has 5 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 6 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Areva Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- Sagent Pharmaceuticals1 product
- Actavis Pharma, Inc.1 product
- Lannett Company, Inc.1 product
- Hisun Pharmaceuticals USA, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (5)
- ANDA076661Sagent Pharms Inc · April 28, 2004
- ANDA078393Fresenius Kabi USA · October 15, 2007
- ANDA078610Actavis Totowa · February 11, 2009
- ANDA090724Areva Pharms · September 27, 2010
- ANDA220196Hisun Pharm Hangzhou · July 23, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1740864, 1740865 |
|---|---|
| SPL set ID of the quoted label | cf5255cc-91fd-4132-973b-764dba142eae |
| FDA labels (SPL) | 5 |
| FDA applications | 5 ANDA |
| Active ingredients (FDA) | FLUDARABINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fludarabine, Fresenius Kabi USA, LLC, effective October 14, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →