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FDA Approval

Aminosyn II

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
ICU Medical Inc.
DUNS: 118380146
Effective Date
May 4, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Leucine(1000 mg in 100 mL)
Methionine(172 mg in 100 mL)
Phenylalanine(298 mg in 100 mL)
Threonine(400 mg in 100 mL)
Tryptophan(200 mg in 100 mL)
Alanine(993 mg in 100 mL)
Arginine(1018 mg in 100 mL)
Aspartic acid(700 mg in 100 mL)
Glutamic acid(738 mg in 100 mL)
acetyl l-tyrosine(270 mg in 100 mL)
Serine(530 mg in 100 mL)
Lysine(1050 mg in 100 mL)
Valine(500 mg in 100 mL)
Histidine(300 mg in 100 mL)
Proline(722 mg in 100 mL)
Isoleucine(660 mg in 100 mL)
Glycine(500 mg in 100 mL)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aminosyn II

Product Details

NDC Product Code
0990-7172
Application Number
NDA020015
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
May 4, 2022
LeucineActive
Code: GMW67QNF9CClass: ACTIBQuantity: 1000 mg in 100 mL
MethionineActive
Code: AE28F7PNPLClass: ACTIBQuantity: 172 mg in 100 mL
PhenylalanineActive
Code: 47E5O17Y3RClass: ACTIBQuantity: 298 mg in 100 mL
ThreonineActive
Code: 2ZD004190SClass: ACTIBQuantity: 400 mg in 100 mL
TryptophanActive
Code: 8DUH1N11BXClass: ACTIBQuantity: 200 mg in 100 mL
AlanineActive
Code: OF5P57N2ZXClass: ACTIBQuantity: 993 mg in 100 mL
ArginineActive
Code: 94ZLA3W45FClass: ACTIBQuantity: 1018 mg in 100 mL
Aspartic acidActive
Code: 30KYC7MIAIClass: ACTIBQuantity: 700 mg in 100 mL
Glutamic acidActive
Code: 3KX376GY7LClass: ACTIBQuantity: 738 mg in 100 mL
acetyl l-tyrosineActive
Code: DA8G610ZO5Class: ACTIBQuantity: 270 mg in 100 mL
SerineActive
Code: 452VLY9402Class: ACTIBQuantity: 530 mg in 100 mL
LysineActive
Code: TTL6G7LIWZClass: ACTIMQuantity: 1050 mg in 100 mL
ValineActive
Code: HG18B9YRS7Class: ACTIBQuantity: 500 mg in 100 mL
HistidineActive
Code: 4QD397987EClass: ACTIBQuantity: 300 mg in 100 mL
ProlineActive
Code: 9DLQ4CIU6VClass: ACTIBQuantity: 722 mg in 100 mL
IsoleucineActive
Code: 04Y7590D77Class: ACTIBQuantity: 660 mg in 100 mL
GlycineActive
Code: TE7660XO1CClass: ACTIBQuantity: 500 mg in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT

Aminosyn II

Product Details

NDC Product Code
0990-7171
Application Number
NDA020041
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
May 4, 2022
LysineActive
Code: TTL6G7LIWZClass: ACTIMQuantity: 1575 mg in 100 mL
ValineActive
Code: HG18B9YRS7Class: ACTIBQuantity: 750 mg in 100 mL
ArginineActive
Code: 94ZLA3W45FClass: ACTIBQuantity: 1527 mg in 100 mL
acetyl l-tyrosineActive
Code: DA8G610ZO5Class: ACTIBQuantity: 405 mg in 100 mL
IsoleucineActive
Code: 04Y7590D77Class: ACTIBQuantity: 990 mg in 100 mL
LeucineActive
Code: GMW67QNF9CClass: ACTIBQuantity: 1500 mg in 100 mL
MethionineActive
Code: AE28F7PNPLClass: ACTIBQuantity: 258 mg in 100 mL
PhenylalanineActive
Code: 47E5O17Y3RClass: ACTIBQuantity: 447 mg in 100 mL
ThreonineActive
Code: 2ZD004190SClass: ACTIBQuantity: 600 mg in 100 mL
TryptophanActive
Code: 8DUH1N11BXClass: ACTIBQuantity: 300 mg in 100 mL
AlanineActive
Code: OF5P57N2ZXClass: ACTIBQuantity: 1490 mg in 100 mL
Aspartic acidActive
Code: 30KYC7MIAIClass: ACTIBQuantity: 1050 mg in 100 mL
Glutamic acidActive
Code: 3KX376GY7LClass: ACTIBQuantity: 1107 mg in 100 mL
HistidineActive
Code: 4QD397987EClass: ACTIBQuantity: 450 mg in 100 mL
ProlineActive
Code: 9DLQ4CIU6VClass: ACTIBQuantity: 1083 mg in 100 mL
SerineActive
Code: 452VLY9402Class: ACTIBQuantity: 795 mg in 100 mL
GlycineActive
Code: TE7660XO1CClass: ACTIBQuantity: 750 mg in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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