FDA Orange Book
Is there a generic for Ethamolin?
Ethamolin contains ethanolamine oleate. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ethamolin (ethanolamine oleate).
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Ethamolin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 50MG/ML | Marketed (Rx) | None | 0 | None |
NDA 019357, held by QOL MEDICAL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ethamolin NDC codes
Questions
Is there a generic for Ethamolin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ethamolin (ethanolamine oleate).
What is the generic name for Ethamolin?
The active ingredient in Ethamolin is ethanolamine oleate, 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.