Drug

Who makes levoleucovorin?

5 companies list levoleucovorin as a human prescription drug, including under the names KHAPZORY. Forms: injection; injection, powder, lyophilized, for solution; injection, solution. Routes: intravenous.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing levoleucovorin

CompanyFormsApplicationNDCsRegistered sites
Dr. Reddy's Laboratories LimitedIndiainjection, solutionANDAANDA210892215
GLAND PHARMA LIMITEDIndiainjectionANDAANDA21089224
Hikma Pharmaceuticals USA Inc.United Statesinjection, powder, lyophilized, for solutionANDAANDA20626314
Amneal Ireland LimitedIrelandinjection, solutionANDAANDA20754811
Acrotech Biopharma Incinjection, powder, lyophilized, for solutionNDANDA21122610

Orange Book patents

1 unexpired patent lists levoleucovorin as the active ingredient, expiring between Mar 2039 and Mar 2039. Application holder: ACROTECH BIOPHARMA INC.

Enquiry

Common questions

Who makes levoleucovorin?
5 companies list levoleucovorin as a human prescription drug in the openFDA NDC Directory, led by Dr. Reddy's Laboratories Limited, GLAND PHARMA LIMITED, Hikma Pharmaceuticals USA Inc., Amneal Ireland Limited, Acrotech Biopharma Inc. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic KHAPZORY?
4 companies list levoleucovorin under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.