Details for New Drug Application (NDA): 211190

NDA 211190 describes DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, and Hospira, and is included in five NDAs. It is available from three suppliers. Additional details are available on the DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is dextrose; sodium chloride. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the dextrose; sodium chloride profile page.

Summary for 211190

Tradename:	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	dextrose; sodium chloride
Patents:	0

Pharmacology for NDA: 211190

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Suppliers and Packaging for NDA: 211190

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	211190	ANDA	Fresenius Kabi USA, LLC	63323-874	63323-874-10	10 BAG in 1 CASE (63323-874-10) / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2.5GM/100ML;450MG/100ML
Approval Date:	Dec 20, 2019	TE:	AP	RLD:	No

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