FDA Orange Book
Generic for Nolvadex
Nolvadex contains tamoxifen. 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 Nolvadex is tamoxifen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Nolvadex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 10MG BASE | Discontinued | None | 5 | AB |
| tablet, oral | EQ 20MG BASE | Discontinued | None | 5 | AB |
NDA 017970, held by ASTRAZENECA PHARMACEUTICALS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tamoxifen
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 070929 | AB (A-rated, therapeutically equivalent) | February 20, 2003 | EQ 10MG BASE, EQ 20MG BASE |
| DR REDDYS LABORATORIES SA | 075797 | AB (A-rated, therapeutically equivalent) | February 20, 2003 | EQ 10MG BASE, EQ 20MG BASE |
| MYLAN PHARMACEUTICALS INC | 074732 | AB (A-rated, therapeutically equivalent) | February 20, 2003 | EQ 10MG BASE, EQ 20MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 206694 | AB (A-rated, therapeutically equivalent) | October 27, 2017 | EQ 10MG BASE, EQ 20MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 213358 | AB (A-rated, therapeutically equivalent) | August 14, 2020 | EQ 10MG BASE, EQ 20MG BASE |
Questions
Is there a generic for Nolvadex?
Yes. The generic name for Nolvadex is tamoxifen. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Nolvadex?
The active ingredient in Nolvadex is tamoxifen, 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.