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Generated: November 22, 2018

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Details for New Drug Application (NDA): 017673

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NDA 017673 describes AMINOSYN 8.5% 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 8.5% W/ELECTROLYTES profile page.

The generic ingredient in AMINOSYN 8.5% W/ELECTROLYTES is amino acids; magnesium chloride; potassium chloride; sodium chloride; sodium phosphate, dibasic. 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 chloride; sodium chloride; sodium phosphate, dibasic profile page.
Suppliers and Packaging for NDA: 017673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINOSYN 10% amino acids INJECTABLE;INJECTION 017673 NDA Hospira, Inc. 0409-4187 0409-4187-03 12 POUCH in 1 CASE (0409-4187-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
AMINOSYN 10% (PH6) amino acids INJECTABLE;INJECTION 017673 NDA Hospira, Inc. 0409-4187 0409-4187-03 12 POUCH in 1 CASE (0409-4187-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5% (5GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength7% (7GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10% (10GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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