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Generated: November 21, 2018

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Details for New Drug Application (NDA): 019492

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NDA 019492 describes AMINOSYN-PF 10%, 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-PF 10% profile page.

The generic ingredient in AMINOSYN-PF 10% is amino acids. There are three hundred and forty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 019492
Tradename:AMINOSYN-PF 10%
Applicant:Icu Medical Inc
Ingredient:amino acids
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019492
Ingredient-typeAmino Acids
Suppliers and Packaging for NDA: 019492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMINOSYN-PF 10% amino acids INJECTABLE;INJECTION 019492 NDA Hospira, Inc. 0409-4179 0409-4179-05 6 BAG in 1 CASE (0409-4179-05) > 1000 mL in 1 BAG

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10% (10GM/100ML)
Approval Date:Oct 17, 1986TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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