FDA Orange Book
Generic for Delatestryl
Delatestryl contains testosterone enanthate. 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 Delatestryl is testosterone enanthate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
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Delatestryl products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 200MG/ML | Discontinued | None | 3 | AO |
| injectable, injection | 200MG/ML | Discontinued | None | 3 | AO |
NDA 009165, held by ENDO PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic testosterone enanthate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NEXUS PHARMACEUTICALS LLC | 040575 | AO (A-rated, therapeutically equivalent) | June 14, 2006 | 200MG/ML, 200MG/ML |
| HIKMA FARMACEUTICA PORTUGAL SA | 091120 | AO (A-rated, therapeutically equivalent) | September 18, 2012 | 200MG/ML, 200MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 212659 | AO (A-rated, therapeutically equivalent) | February 28, 2024 | 200MG/ML, 200MG/ML |
Questions
Is there a generic for Delatestryl?
Yes. The generic name for Delatestryl is testosterone enanthate. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AO.
What is the generic name for Delatestryl?
The active ingredient in Delatestryl is testosterone enanthate, 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.