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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 217263

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NDA 217263 describes DEXTROSE 5%, which is a drug marketed by Am Regent, Baxter Hlthcare, Fresenius Kabi Usa, Otsuka Icu Medcl, Hospira, B Braun, Miles, Abbott, DHL, Icu Medical Inc, and Intl Medication Sys, and is included in fifty-eight NDAs. Additional details are available on the DEXTROSE 5% profile page.

The generic ingredient in DEXTROSE 5% is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.

Summary for 217263

Tradename:	DEXTROSE 5%
Applicant:	Am Regent
Ingredient:	dextrose
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Apr 8, 2024	TE:		RLD:	No

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