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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019631

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NDA 019631 describes DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abbott, B Braun, Icu Medical Inc, and Miles, and is included in five NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.
Summary for 019631
Tradename:DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:B Braun
Ingredient:dextrose; sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019631
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7605 N 0264-7605-00
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631 NDA B. Braun Medical Inc. 0264-7608 N 0264-7608-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/100ML;110MG/100ML
Approval Date:Feb 24, 1988TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/100ML;200MG/100ML
Approval Date:Feb 24, 1988TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2.5GM/100ML;330MG/100ML
Approval Date:Feb 24, 1988TE:RLD:No

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