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Last Updated: May 20, 2022

Details for New Drug Application (NDA): 019018

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NDA 019018 describes TROPHAMINE 10%, which is a drug marketed by B Braun and is included in one NDA. It is available from one supplier. Additional details are available on the TROPHAMINE 10% profile page.

The generic ingredient in TROPHAMINE 10% is amino acids. There are three hundred and fifty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the amino acids profile page.
Summary for 019018
Tradename:TROPHAMINE 10%
Applicant:B Braun
Ingredient:amino acids
Formulation / Manufacturing:see details
Pharmacology for NDA: 019018
Suppliers and Packaging for NDA: 019018
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TROPHAMINE amino acids INJECTABLE;INJECTION 019018 NDA B. Braun Medical Inc. 0264-1933 0264-1933-10 12 CONTAINER in 1 CASE (0264-1933-10) > 500 mL in 1 CONTAINER
TROPHAMINE amino acids INJECTABLE;INJECTION 019018 NDA B. Braun Medical Inc. 0264-9341 0264-9341-55 6 CARTON in 1 CASE (0264-9341-55) > 1 CONTAINER in 1 CARTON > 500 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6% (6GM/100ML)
Approval Date:Jul 20, 1984TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10% (10GM/100ML)
Approval Date:Sep 7, 1988TE:RLD:Yes

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