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Generated: November 15, 2018

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Details for New Drug Application (NDA): 016822

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NDA 016822 describes FREAMINE III 8.5% W/ ELECTROLYTES, 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 FREAMINE III 8.5% W/ ELECTROLYTES profile page.

The generic ingredient in FREAMINE III 8.5% W/ ELECTROLYTES is amino acids; magnesium acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate. 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 acetate; phosphoric acid; potassium acetate; potassium chloride; sodium acetate profile page.
Pharmacology for NDA: 016822
Ingredient-typeAmino Acids
Suppliers and Packaging for NDA: 016822
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FREAMINE 8.5% amino acids INJECTABLE;INJECTION 016822 NDA B. Braun Medical Inc. 0264-9010 0264-9010-55 6 CARTON in 1 CASE (0264-9010-55) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER
FREAMINE HBC 6.9% amino acids INJECTABLE;INJECTION 016822 NDA B. Braun Medical Inc. 0264-9010 0264-9010-55 6 CARTON in 1 CASE (0264-9010-55) > 1 CONTAINER in 1 CARTON > 1000 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength8.5% (8.5GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength8.5% (8.5GM/100ML)
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength3%;54MG/100ML;40MG/100ML;150MG/100ML;200MG/100ML;120MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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