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Last Updated: July 19, 2024

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 fifty 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019492
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 ICU Medical Inc. 0990-4179 0990-4179-05 6 BAG in 1 CASE (0990-4179-05) / 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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