FDA Orange Book
Generic for Freamine III
Freamine III contains amino acids. 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 Freamine III is amino acids. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Freamine III products the Orange Book lists.
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Freamine III products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10% (10GM/100ML) | Discontinued | None | 1 | None |
| injectable, injection | 8.5% (8.5GM/100ML) | Discontinued | None | 0 | None |
NDA 016822, held by B BRAUN MEDICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amino acids
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAXTER HEALTHCARE CORP | 075880 | None (No TE code listed) | June 19, 2003 | 10% (10GM/100ML) |
Questions
Is there a generic for Freamine III?
Yes. The generic name for Freamine III is amino acids. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 2 Freamine III products the Orange Book lists.
What is the generic name for Freamine III?
The active ingredient in Freamine III is amino acids, 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.