FDA Orange Book
Generic for Aminosyn
Aminosyn 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 Aminosyn is amino acids. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 5 Aminosyn products the Orange Book lists.
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Aminosyn 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 | 3.5% (3.5GM/100ML) | Discontinued | None | 0 | None |
| injectable, injection | 5% (5GM/100ML) | Discontinued | None | 0 | None |
| injectable, injection | 7% (7GM/100ML) | Discontinued | None | 0 | None |
| injectable, injection | 8.5% (8.5GM/100ML) | Discontinued | None | 0 | None |
NDA 017673, 017789, held by ICU 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 Aminosyn?
Yes. The generic name for Aminosyn is amino acids. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 1 of the 5 Aminosyn products the Orange Book lists.
What is the generic name for Aminosyn?
The active ingredient in Aminosyn 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.