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Generated: November 14, 2018

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Details for New Drug Application (NDA): 019345

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NDA 019345 describes DEXTROSE 30% 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 30% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 30% 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 019345
Tradename:DEXTROSE 30% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:dextrose
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 30% IN PLASTIC CONTAINER dextrose INJECTABLE;INJECTION 019345 NDA Hospira, Inc. 0409-8004 0409-8004-15 12 POUCH in 1 CASE (0409-8004-15) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30GM/100ML
Approval Date:Jan 26, 1985TE:RLD:Yes

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