Quick answers
- What is Thiotepa used for?
- The FDA-approved label (Tepadina, Amneal Pharmaceuticals LLC, January 30, 2026) says: “TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1, 14) For treatment of adenocarcinoma of the breast or ovary. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Thiotepa have a boxed warning?
- Yes. The FDA label for Tepadina has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Thiotepa?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Thiotepa been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Thiotepa?
- 8 companies list prescription products of Thiotepa in the FDA NDC Directory, including Amneal Pharmaceuticals LLC, Hikma Pharmaceuticals USA Inc. and Dr. Reddy's Laboratories Inc..
What Thiotepa is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TEPADINA (thiotepa) is an alkylating drug indicated: To reduce the risk of graft rejection when used in conjunction with high-dose busulfan and cyclophosphamide as a preparative regimen for allogeneic hematopoietic progenitor (stem) cell transplantation (HSCT) for pediatric patients with class 3 beta-thalassemia. (1.1, 14) For treatment of adenocarcinoma of the breast or ovary. …
— FDA label: Tepadina, Amneal Pharmaceuticals LLC, effective January 30, 2026. Read the full label on DailyMed →
The FDA has 11 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.
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 →
7 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, powder, for solution |
|---|---|
| Route | Intracavitary · Intravenous · Intravesical |
| Prescription products | 17 in the FDA NDC Directory |
| Brand names | Tepadina |
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.
- Amneal Pharmaceuticals LLC4 products
- Hikma Pharmaceuticals USA Inc.3 products
- Dr. Reddy's Laboratories Inc.2 products
- Novadoz Pharmaceuticals LLC2 products
- Meitheal Pharmaceuticals Inc.2 products
- Gland Pharma Limited2 products
- Fresenius Kabi USA, LLC1 product
- Sagent Pharmaceuticals1 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 |
|---|---|---|---|
| NDA208264 TEPADINA, TEPADINA AND SODIUM CHLORIDE | Adienne SA | January 26, 2017 | 5, latest January 15, 2026 2026: Manufacturing (CMC) · 2025: Manufacturing (CMC) · 2025: Manufacturing (CMC) |
Generic approvals (7)
- ANDA075547West-Ward Pharms Int · April 2, 2001
- ANDA209150Hengrui Pharma · May 4, 2018
- ANDA210337DR Reddys · May 4, 2018
- ANDA213049Msn · March 4, 2020
- ANDA214222Gland · March 8, 2021
- ANDA211755Hikma · September 5, 2023
- ANDA216037Meitheal · December 26, 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) — Tepadina, Amneal Pharmaceuticals LLC, effective January 30, 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 →