FDA Orange Book
Generic for Tepadina
Tepadina contains thiotepa. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tepadina is thiotepa. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Tepadina products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intracavitary, intravenous, intravesical | 100MG/VIAL | Marketed (Rx) | AP | 4 | AP |
| powder, intracavitary, intravenous, intravesical | 15MG/VIAL | Marketed (Rx) | AP | 4 | AP |
NDA 208264, held by ADIENNE SA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic thiotepa
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MSN LABORATORIES PRIVATE LTD | 213049 | AP (A-rated, therapeutically equivalent) | March 4, 2020 | 100MG/VIAL, 15MG/VIAL |
| GLAND PHARMA LTD | 214222 | AP (A-rated, therapeutically equivalent) | January 3, 2022 | 100MG/VIAL, 15MG/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 211755 | AP (A-rated, therapeutically equivalent) | September 5, 2023 | 100MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 216037 | AP (A-rated, therapeutically equivalent) | December 26, 2023 | 100MG/VIAL, 15MG/VIAL |
| REGCON HOLDINGS LLC | 217559 | AP (A-rated, therapeutically equivalent) | August 20, 2024 | 15MG/VIAL |
Tepadina NDC codes
Questions
Is there a generic for Tepadina?
Yes. The generic name for Tepadina is thiotepa. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Tepadina?
The active ingredient in Tepadina is thiotepa, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.