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Prescription medicine

Melphalan HCL

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

Is there a shortage of Melphalan HCL?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Melphalan HCL been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Melphalan HCL?
2 companies list prescription products of Melphalan HCL in the FDA NDC Directory, including Apotex Corp. and Acrotech Biopharma Inc.

What Melphalan HCL is used for

We did not find an “Indications and Usage” section in the FDA labels for this medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Forms and how it is given

Dosage formsInjection, solution · Injection, powder, lyophilized, for solution
RouteIntravenous
Prescription products2 in the FDA NDC Directory
Brand namesIvra, Evomela

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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA207155
EVOMELA
Acrotech BiopharmaMarch 10, 2016 3, latest April 26, 2022
2022: Labeling · 2021: Labeling · 2017: Manufacturing (CMC)
NDA217110
IVRA
ApotexAugust 18, 2023 1, latest July 22, 2024
2024: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

FDA labels (SPL)0
FDA applicationsNDA207155, NDA217110
Active ingredients (FDA)MELPHALAN HYDROCHLORIDE

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. 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 →

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