Details for New Drug Application (NDA): 016673

NDA 016673 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 016673

Tradename:	DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare
Ingredient:	dextrose
Patents:	0

Suppliers and Packaging for NDA: 016673

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	016673	NDA	Baxter Healthcare Corporation	0338-0017	0338-0017-02	250 mL in 1 BAG (0338-0017-02)
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	016673	NDA	Baxter Healthcare Corporation	0338-0017	0338-0017-03	500 mL in 1 BAG (0338-0017-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5GM/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Oct 30, 1985	TE:	AP	RLD:	Yes

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