FDA Orange Book
Generic for Aminosyn II
Aminosyn II 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 II 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 II products the Orange Book lists.
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Aminosyn II 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 019438, 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 II?
Yes. The generic name for Aminosyn II 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 II products the Orange Book lists.
What is the generic name for Aminosyn II?
The active ingredient in Aminosyn II 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.