Quick answers
- What is Tepadina?
- Tepadina is a brand name of Thiotepa, a prescription medicine. The FDA NDC Directory lists 4 Tepadina products in 4 strengths and forms.
- Who makes Tepadina?
- Adienne Sa holds the FDA application for Tepadina (NDA208264, approved January 26, 2017).
- Is there a generic or store brand of Tepadina?
- Yes. The FDA NDC Directory lists 2 other products with the same active ingredients, strength and form as a Tepadina product, 2 of them generic. Ask your pharmacist whether one is right for you.
- Has Tepadina been recalled?
- No recall linked to Tepadina products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Tepadina is
Each Tepadina product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Thiotepa · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| thiotepa 100 mg injection, powder, for solution (intracavitary, intravenous, intravesical) | Tepadina | 1 product, 1 company | DailyMed |
| thiotepa 15 mg injection, powder, for solution (intracavitary, intravenous, intravesical) | Tepadina | 1 product, 1 company | DailyMed |
| thiotepa 200 mg injection, powder, lyophilized, for solution (intracavitary, intravenous, intravesical) | Tepadina | None listed | DailyMed |
| thiotepa 400 mg injection, powder, lyophilized, for solution (intracavitary, intravenous, intravesical) | Tepadina | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Thiotepa →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA208264 | Adienne Sa | January 26, 2017 | 4 |
Companies that list Tepadina
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Tepadina products.
- Amneal Pharmaceuticals LLC4 products
Recalls
No recall linked to Tepadina products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.