FDA Orange Book
Generic for Avodart
Avodart contains dutasteride. 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 Avodart is dutasteride. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Avodart products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 0.5MG | Marketed (Rx) | AB | 10 | AB |
NDA 021319, held by WAYLIS THERAPEUTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dutasteride
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BARR LABORATORIES INC | 090095 | AB (A-rated, therapeutically equivalent) | December 21, 2010 | 0.5MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 203118 | AB (A-rated, therapeutically equivalent) | November 20, 2015 | 0.5MG |
| AUROBINDO PHARMA LTD | 202660 | AB (A-rated, therapeutically equivalent) | November 20, 2015 | 0.5MG |
| CHARTWELL LIFE MOLECULES LLC | 200899 | AB (A-rated, therapeutically equivalent) | November 20, 2015 | 0.5MG |
| ONESOURCE SOFTGELS PTE LTD | 204262 | AB (A-rated, therapeutically equivalent) | November 20, 2015 | 0.5MG |
| ACELLA PHARMACEUTICALS LLC | 206373 | AB (A-rated, therapeutically equivalent) | March 17, 2016 | 0.5MG |
| ASCENT PHARMACEUTICALS INC | 206574 | AB (A-rated, therapeutically equivalent) | October 21, 2016 | 0.5MG |
| PHARMAZONE | 204376 | AB (A-rated, therapeutically equivalent) | April 7, 2017 | 0.5MG |
| ZYDUS LIFESCIENCES LTD | 204373 | AB (A-rated, therapeutically equivalent) | October 4, 2017 | 0.5MG |
| HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD | 209909 | AB (A-rated, therapeutically equivalent) | November 21, 2017 | 0.5MG |
Questions
Is there a generic for Avodart?
Yes. The generic name for Avodart is dutasteride. 10 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 Avodart?
The active ingredient in Avodart is dutasteride, 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.