Last Updated: September 29, 2026

Details for New Drug Application (NDA): 019438

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NDA 019438 describes AMINOSYN II 8.5%, which is a drug marketed by Icu Medical Inc and is included in two NDAs. Additional details are available on the AMINOSYN II 8.5% profile page.

The generic ingredient in AMINOSYN II 8.5% is amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic. There are three drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic profile page.

Summary for 019438

Tradename:	AMINOSYN II 8.5%
Applicant:	Icu Medical Inc
Ingredient:	amino acids
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	3.5% (3.5GM/100ML)
Approval Date:	Apr 3, 1986	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	5% (5GM/100ML)
Approval Date:	Apr 3, 1986	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	7% (7GM/100ML)
Approval Date:	Apr 3, 1986	TE:		RLD:	No

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