Quick answers
- What is Levoleucovorin used for?
- The FDA-approved label (Khapzory, Acrotech Biopharma Inc, March 17, 2026) says: “KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Levoleucovorin have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Levoleucovorin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Levoleucovorin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Levoleucovorin?
- 8 companies list prescription products of Levoleucovorin in the FDA NDC Directory, including Dr. Reddy's Laboratories Inc., Gland Pharma Limited and Slate Run Pharmaceuticals.
What Levoleucovorin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
KHAPZORY is indicated for: rescue after high-dose methotrexate therapy in adult and pediatric patients with osteosarcoma. diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination adult and pediatric patients. The treatment of adults with metastatic colorectal cancer in combination with fluorouracil. …
— FDA label: Khapzory, Acrotech Biopharma Inc, effective March 17, 2026. Read the full label on DailyMed →
The FDA has 9 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.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection, powder, lyophilized, for solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Khapzory |
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.
- Dr. Reddy's Laboratories Inc.2 products
- Gland Pharma Limited2 products
- Slate Run Pharmaceuticals2 products
- Hainan Poly Pharm. Co., Ltd.2 products
- Meitheal Pharmaceuticals Inc.2 products
- Hikma Pharmaceuticals USA Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Acrotech Biopharma Inc1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA211226 KHAPZORY | Acrotech Biopharma | October 19, 2018 | 1, latest March 3, 2020 2020: Labeling |
Generic approvals (6)
- ANDA206263Hikma · June 16, 2016
- ANDA207548Amneal · September 8, 2017
- ANDA210892Gland · September 14, 2018
- ANDA211002Meitheal · August 16, 2019
- ANDA211003Meitheal · August 22, 2019
- ANDA217314Hainan Poly Pharm · May 22, 2023
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Khapzory, Acrotech Biopharma Inc, effective March 17, 2026; 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 →