FDA Orange Book
Is there a generic for Tepadina and Sodium Chloride?
Tepadina and Sodium Chloride 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tepadina and Sodium Chloride (thiotepa). The Orange Book shows its last listed patent expires May 31, 2037.
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Tepadina and Sodium Chloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 200MG | Marketed (Rx) | None | 0 | None |
| powder, intravenous | 400MG | Marketed (Rx) | None | 0 | None |
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.
Tepadina and Sodium Chloride patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9931458 | May 31, 2037 | Drug product | None | 208264 |
Tepadina and Sodium Chloride NDC codes
Questions
Is there a generic for Tepadina and Sodium Chloride?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tepadina and Sodium Chloride (thiotepa). The Orange Book shows its last listed patent expires May 31, 2037.
What is the generic name for Tepadina and Sodium Chloride?
The active ingredient in Tepadina and Sodium Chloride is thiotepa, per the FDA Orange Book.
When does the Tepadina and Sodium Chloride patent expire?
The last patent listed for Tepadina and Sodium Chloride in the Orange Book expires May 31, 2037. A listed patent expiry date is not a generic launch date.
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.