FDA Orange Book
Generic for Nilandron
Nilandron contains nilutamide. 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 Nilandron is nilutamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Nilandron products the Orange Book lists.
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Nilandron products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Discontinued | None | 1 | None |
| tablet, oral | 50MG | Discontinued | None | 0 | None |
NDA 020169, held by ADVANZ PHARMA (US) CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nilutamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 207631 | None (No TE code listed) | July 15, 2016 | 150MG |
Questions
Is there a generic for Nilandron?
Yes. The generic name for Nilandron is nilutamide. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Nilandron products the Orange Book lists.
What is the generic name for Nilandron?
The active ingredient in Nilandron is nilutamide, 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.