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Generated: November 12, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018080

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NDA 018080 describes DEXTROSE 10% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Miles, and is included in eleven NDAs. It is available from three suppliers. Additional details are available on the DEXTROSE 10% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 10% 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 018080
Tradename:DEXTROSE 10% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018080
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 018080 NDA Hospira, Inc. 0409-7930 0409-7930-02 24 POUCH in 1 CASE (0409-7930-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG
DEXTROSE 10% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 018080 NDA Hospira, Inc. 0409-7930 0409-7930-03 24 POUCH in 1 CASE (0409-7930-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10GM/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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