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Generated: November 15, 2018

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Details for New Drug Application (NDA): 018931

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NDA 018931 describes TRAVASOL 8.5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the TRAVASOL 8.5% IN PLASTIC CONTAINER profile page.

The generic ingredient in TRAVASOL 8.5% IN PLASTIC CONTAINER is amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride. There are three hundred and forty-eight drug master file entries for this compound. Additional details are available on the amino acids; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chloride profile page.
Summary for 018931
Tradename:TRAVASOL 8.5% IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:amino acids
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018931
Ingredient-typeAmino Acids
Suppliers and Packaging for NDA: 018931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAVASOL 10% IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 018931 NDA Baxter Healthcare Corporation 0338-0644 0338-0644-03 500 mL in 1 BAG (0338-0644-03)
TRAVASOL 10% IN PLASTIC CONTAINER amino acids INJECTABLE;INJECTION 018931 NDA Baxter Healthcare Corporation 0338-0644 0338-0644-04 1000 mL in 1 BAG (0338-0644-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5.5% (5.5GM/100ML)
Approval Date:Aug 23, 1984TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength8.5% (8.5GM/100ML)
Approval Date:Aug 23, 1984TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10% (10MG/100ML)
Approval Date:Aug 23, 1984TE:RLD:No

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