MedPath
FDA Product

Aminosyn II

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Aminosyn II

0990-7172

Regulatory Information

0990-7172

NDA020015

C73594

May 4, 2022

USA

Aminosyn II

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

ICU Medical Inc.

118380146

Active Ingredients

LEUCINE

Quantity: 1000 mg in 100 mL

Code: GMW67QNF9C

Class Code: ACTIB

METHIONINE

Quantity: 172 mg in 100 mL

Code: AE28F7PNPL

Class Code: ACTIB

PHENYLALANINE

Quantity: 298 mg in 100 mL

Code: 47E5O17Y3R

Class Code: ACTIB

THREONINE

Quantity: 400 mg in 100 mL

Code: 2ZD004190S

Class Code: ACTIB

TRYPTOPHAN

Quantity: 200 mg in 100 mL

Code: 8DUH1N11BX

Class Code: ACTIB

ALANINE

Quantity: 993 mg in 100 mL

Code: OF5P57N2ZX

Class Code: ACTIB

ARGININE

Quantity: 1018 mg in 100 mL

Code: 94ZLA3W45F

Class Code: ACTIB

ASPARTIC ACID

Quantity: 700 mg in 100 mL

Code: 30KYC7MIAI

Class Code: ACTIB

GLUTAMIC ACID

Quantity: 738 mg in 100 mL

Code: 3KX376GY7L

Class Code: ACTIB

ACETYL L-TYROSINE

Quantity: 270 mg in 100 mL

Code: DA8G610ZO5

Class Code: ACTIB

SERINE

Quantity: 530 mg in 100 mL

Code: 452VLY9402

Class Code: ACTIB

LYSINE ACETATE

Quantity: 1050 mg in 100 mL

Code: TTL6G7LIWZ

Class Code: ACTIM

VALINE

Quantity: 500 mg in 100 mL

Code: HG18B9YRS7

Class Code: ACTIB

HISTIDINE

Quantity: 300 mg in 100 mL

Code: 4QD397987E

Class Code: ACTIB

PROLINE

Quantity: 722 mg in 100 mL

Code: 9DLQ4CIU6V

Class Code: ACTIB

ISOLEUCINE

Quantity: 660 mg in 100 mL

Code: 04Y7590D77

Class Code: ACTIB

GLYCINE

Quantity: 500 mg in 100 mL

Code: TE7660XO1C

Class Code: ACTIB

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

Active Moieties

LEUCINE

Code: GMW67QNF9C

ISOLEUCINE

Code: 04Y7590D77

LYSINE

Code: K3Z4F929H6

METHIONINE

Code: AE28F7PNPL

PHENYLALANINE

Code: 47E5O17Y3R

THREONINE

Code: 2ZD004190S

TRYPTOPHAN

Code: 8DUH1N11BX

ALANINE

Code: OF5P57N2ZX

HISTIDINE

Code: 4QD397987E

VALINE

Code: HG18B9YRS7

ARGININE

Code: 94ZLA3W45F

ASPARTIC ACID

Code: 30KYC7MIAI

SERINE

Code: 452VLY9402

GLUTAMIC ACID

Code: 3KX376GY7L

PROLINE

Code: 9DLQ4CIU6V

N-ACETYLTYROSINE

Code: DA8G610ZO5

GLYCINE

Code: TE7660XO1C

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