FDA Orange Book
Generic for Entadfi
Entadfi contains finasteride and tadalafil. 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 Entadfi is finasteride and tadalafil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Entadfi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 5MG;5MG | Discontinued | None | 1 | None |
NDA 215423, held by BLUE WATER BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic finasteride and tadalafil
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVITIUM PHARMA LLC | 218499 | None (No TE code listed) | March 19, 2025 | 5MG;5MG |
Questions
Is there a generic for Entadfi?
Yes. The generic name for Entadfi is finasteride and tadalafil. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Entadfi?
The active ingredient in Entadfi is finasteride and tadalafil, 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.