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Generated: November 22, 2018

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Details for New Drug Application (NDA): 018564

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NDA 018564 describes DEXTROSE 20% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the DEXTROSE 20% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 20% IN PLASTIC CONTAINER is dextrose. There are eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 018564
Tradename:DEXTROSE 20% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 20% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 018564 NDA Hospira, Inc. 0409-7935 0409-7935-19 12 POUCH in 1 CASE (0409-7935-19) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20GM/100ML
Approval Date:Mar 23, 1982TE:RLD:Yes

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