FDA Orange Book
Generic for Tepanil
Tepanil contains diethylpropion. 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 Tepanil is diethylpropion. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Tepanil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 25MG | Discontinued | None | 2 | AA |
NDA 011673, held by 3M PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic diethylpropion
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AVANTHI INC | 201212 | AA (A-rated, therapeutically equivalent) | December 22, 2010 | 25MG |
| LANNETT CO INC | 200177 | AA (A-rated, therapeutically equivalent) | July 18, 2011 | 25MG |
Questions
Is there a generic for Tepanil?
Yes. The generic name for Tepanil is diethylpropion. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Tepanil?
The active ingredient in Tepanil is diethylpropion, 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.