FDA Orange Book
Generic for Cosmegen
Cosmegen contains dactinomycin. 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 Cosmegen is dactinomycin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Cosmegen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 0.5MG/VIAL | Discontinued | None | 4 | AP |
NDA 050682, held by RECORDATI RARE DISEASES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dactinomycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EUGIA PHARMA SPECIALITIES LTD | 203385 | AP (A-rated, therapeutically equivalent) | November 9, 2017 | 0.5MG/VIAL |
| XGEN PHARMACEUTICALS DJB INC | 203999 | AP (A-rated, therapeutically equivalent) | May 20, 2019 | 0.5MG/VIAL |
| HISUN PHARMACEUTICAL HANGZHOU CO LTD | 207232 | AP (A-rated, therapeutically equivalent) | July 16, 2019 | 0.5MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 213463 | AP (A-rated, therapeutically equivalent) | November 13, 2020 | 0.5MG/VIAL |
Questions
Is there a generic for Cosmegen?
Yes. The generic name for Cosmegen is dactinomycin. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Cosmegen?
The active ingredient in Cosmegen is dactinomycin, 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.