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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 019445


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NDA 019445 describes DEXTROSE 50%, which is a drug marketed by Hospira, Intl Medication Sys, Baxter Hlthcare, and Icu Medical Inc, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the DEXTROSE 50% profile page.

The generic ingredient in DEXTROSE 50% is dextrose. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextrose profile page.
Summary for 019445
Tradename:DEXTROSE 50%
Applicant:Hospira
Ingredient:dextrose
Patents:0
Suppliers and Packaging for NDA: 019445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 25% dextrose INJECTABLE;INJECTION 019445 NDA Henry Schein, Inc. 0404-9844 0404-9844-10 1 SYRINGE in 1 BAG (0404-9844-10) / 10 mL in 1 SYRINGE
DEXTROSE 25% dextrose INJECTABLE;INJECTION 019445 NDA Henry Schein, Inc. 0404-9845 0404-9845-50 1 SYRINGE in 1 BAG (0404-9845-50) / 50 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/ML
Approval Date:Jun 3, 1986TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/ML
Approval Date:Nov 23, 1998TE:RLD:Yes

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