Details for New Drug Application (NDA): 016367

NDA 016367 describes DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Otsuka Icu Medcl, Hospira, B Braun, Miles, Abbott, Fresenius Kabi Usa, DHL, and Icu Medical Inc, and is included in forty-nine NDAs. It is available from eight 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 016367

Tradename:	DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Otsuka Icu Medcl
Ingredient:	dextrose
Patents:	0

Suppliers and Packaging for NDA: 016367

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	016367	NDA	ICU Medical, Inc.	0990-7922	0990-7922-02	24 POUCH in 1 CASE (0990-7922-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG
DEXTROSE 5% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	016367	NDA	ICU Medical, Inc.	0990-7922	0990-7922-03	24 POUCH in 1 CASE (0990-7922-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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