FDA Orange Book

Generic for Aminosyn-pf

Aminosyn-pf 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-pf 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 Aminosyn-pf products the Orange Book lists.

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Aminosyn-pf products in the Orange Book

Aminosyn-pf products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
injectable, injection10% (10GM/100ML)Marketed (Rx)None1None
injectable, injection7% (7GM/100ML)Marketed (Rx)None0None

NDA 019492, 019398, held by OTSUKA ICU MEDICAL LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic amino acids

Approved generic versions of Aminosyn-pf
CompanyANDATE codeApprovedStrengths
BAXTER HEALTHCARE CORP075880None (No TE code listed)June 19, 200310% (10GM/100ML)

Aminosyn-pf NDC codes

Questions

Is there a generic for Aminosyn-pf?

Yes. The generic name for Aminosyn-pf 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 Aminosyn-pf products the Orange Book lists.

What is the generic name for Aminosyn-pf?

The active ingredient in Aminosyn-pf 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.

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