Is Aminosyn II 4.25% In Dextrose 20% In Plastic Container still available?

Aminosyn II 4.25% In Dextrose 20% In Plastic Container (NDA 019681) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Aminosyn II 4.25% In Dextrose 20% In Plastic Container have a generic?

The FDA Orange Book does not currently list an approved generic (ANDA) sharing Aminosyn II 4.25% In Dextrose 20% In Plastic Container's active ingredient (Amino Acids; Dextrose).

What is Aminosyn II 4.25% In Dextrose 20% In Plastic Container's FDA application number?

Aminosyn II 4.25% In Dextrose 20% In Plastic Container is approved under NDA 019681, held by Hospira.

Orange Book product · Brand (NDA)

Aminosyn II 4.25% In Dextrose 20% In Plastic Container

Amino Acids; Dextrose

Brand (NDA)NDA 019681Discontinued Hospira

Approved

Nov 01, 1988

Application

Brand (NDA)

TE code

Not listed

Listed patents

Aminosyn II 4.25% In Dextrose 20% In Plastic Container (Amino Acids; Dextrose) is Hospira's brand-name drug, approved by the FDA under NDA 019681 in 1988. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Nov 01, 1988
38 yr 3 mo ago
Today

FDA product record

Pharmaceutical detail

Active ingredient

AMINO ACIDS; DEXTROSE

Strength

4.25%;20GM/100ML

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 019681

Product number

005

Marketing status

Discontinued

Reference listed drug (RLD)

Reference standard (RS)

Same application

Other strengths in NDA 019681

Brand + generics

Active-ingredient family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

View full Amino Acids; Dextrose family

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Aminosyn II 4.25% In Dextrose 20% In Plastic Container — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Amino Acids; Dextrose active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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