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Federal Trade Commission
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Accenture
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017634

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NDA 017634 describes DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs. It is available from one supplier. Additional details are available on the DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% 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.
Summary for 017634
Suppliers and Packaging for NDA: 017634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634 NDA Baxter Healthcare Corporation 0338-0683 N 0338-0683-04
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634 NDA Baxter Healthcare Corporation 0338-0683 N 0338-0683-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;150MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;300MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;224MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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