FDA Orange Book
Generic for Thioplex
Thioplex 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 Thioplex is thiotepa. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Thioplex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 15MG/VIAL | Discontinued | None | 4 | AP |
NDA 020058, held by IMMUNEX CORP. 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 |
|---|---|---|---|---|
| WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | 075547 | AP (A-rated, therapeutically equivalent) | April 2, 2001 | 15MG/VIAL |
| DR REDDYS LABORATORIES LTD | 210337 | AP (A-rated, therapeutically equivalent) | May 4, 2018 | 15MG/VIAL |
| PENN LIFE SCIENCES LLC | 208242 | AP (A-rated, therapeutically equivalent) | January 10, 2020 | 15MG/VIAL |
| REGCON HOLDINGS LLC | 211831 | AP (A-rated, therapeutically equivalent) | December 8, 2021 | 15MG/VIAL |
Questions
Is there a generic for Thioplex?
Yes. The generic name for Thioplex is thiotepa. 4 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 Thioplex?
The active ingredient in Thioplex 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.