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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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 hundred and fifty 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
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3.5% (3.5GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5% (5GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength7% (7GM/100ML)
Approval Date:Apr 3, 1986TE:RLD:No

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