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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016678

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NDA 016678 describes DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% IN 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 016678
Tradename:DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Baxter Hlthcare
Ingredient:dextrose; sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 016678
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 016678 NDA Baxter Healthcare Corporation 0338-0089 N 0338-0089-03
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 016678 NDA Baxter Healthcare Corporation 0338-0089 N 0338-0089-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;900MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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