Details for New Drug Application (NDA): 207449

NDA 207449 describes DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Icu Medical Inc, Hospira, B Braun, Miles, Abbott, Fresenius Kabi Usa, and DHL, and is included in forty-nine NDAs. It is available from seven suppliers. Additional details are available on the DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 5% IN PLASTIC CONTAINER 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 207449

Tradename:	DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	dextrose
Patents:	0
Formulation / Manufacturing:	see details

Suppliers and Packaging for NDA: 207449

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	207449	ANDA	Becton Dickinson and Company	17271-720	17271-720-02	60 BAG in 1 CASE (17271-720-02) / 50 mL in 1 BAG
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	207449	ANDA	Becton Dickinson and Company	17271-720	17271-720-03	50 BAG in 1 CASE (17271-720-03) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Oct 21, 2016	TE:	AP	RLD:	No

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