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Generated: December 17, 2018

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Details for New Drug Application (NDA): 019630

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NDA 019630 describes POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, 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 POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is dextrose; potassium chloride; 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; potassium chloride; sodium chloride profile page.
Suppliers and Packaging for NDA: 019630
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630 NDA B. Braun Medical Inc. 0264-7634 0264-7634-00 12 CONTAINER in 1 CASE (0264-7634-00) > 1000 mL in 1 CONTAINER
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630 NDA B. Braun Medical Inc. 0264-7634 0264-7634-00 12 CONTAINER in 1 CASE (0264-7634-00) > 1000 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;37MG/100ML;110MG/100ML
Approval Date:Feb 17, 1988TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;75MG/100ML;110MG/100ML
Approval Date:Feb 17, 1988TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;110MG/100ML;110MG/100ML
Approval Date:Feb 17, 1988TE:RLD:No

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