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Generated: November 18, 2018

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Details for New Drug Application (NDA): 017789

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NDA 017789 describes AMINOSYN 7% W/ ELECTROLYTES, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the AMINOSYN 7% W/ ELECTROLYTES profile page.

The generic ingredient in AMINOSYN 7% W/ ELECTROLYTES is amino acids; magnesium chloride; potassium phosphate, dibasic; sodium chloride. There are three hundred and forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amino acids; magnesium chloride; potassium phosphate, dibasic; sodium chloride profile page.
Summary for 017789
Suppliers and Packaging for NDA: 017789
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINOSYN 3.5% amino acids INJECTABLE;INJECTION 017789 NDA Hospira, Inc. 0409-4196 0409-4196-05 6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG
AMINOSYN 3.5% M amino acids; magnesium acetate; phosphoric acid; potassium acetate; sodium chloride INJECTABLE;INJECTION 017789 NDA Hospira, Inc. 0409-4196 0409-4196-05 6 POUCH in 1 CASE (0409-4196-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7%;102MG/100ML;522MG/100ML;410MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3.5%;21MG/100ML;40MG/100ML;128MG/100ML;234MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3.5% (3.5GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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