Quick answers
- What is Chlorambucil used for?
- The FDA-approved label (Leukeran, Waylis Therapeutics LLC, January 8, 2025) says: “LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chlorambucil have a boxed warning?
- Yes. The FDA label for Leukeran has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Chlorambucil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chlorambucil been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Chlorambucil?
- 1 company lists prescription products of Chlorambucil in the FDA NDC Directory, including Waylis Therapeutics LLC.
What Chlorambucil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
— FDA label: Leukeran, Waylis Therapeutics LLC, effective January 8, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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 →
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Leukeran |
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.
- Waylis Therapeutics LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA010669 LEUKERAN | Waylis Therap | March 18, 1957 | 22, latest October 28, 2011 2011: Labeling · 2010: Labeling · 2005: Labeling |
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) | 105553, 197462 |
|---|---|
| SPL set ID of the quoted label | 58a3c995-5ad6-465d-8437-5970c9088213 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA010669 |
| Active ingredients (FDA) | CHLORAMBUCIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Leukeran, Waylis Therapeutics LLC, effective January 8, 2025; 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 →