Details for New Drug Application (NDA): 209476

NDA 209476 describes SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, and Fresenius Kabi Usa, and is included in three NDAs. It is available from four suppliers. Additional details are available on the SODIUM CHLORIDE 3% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 3% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for 209476

Tradename:	SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	sodium chloride
Patents:	0

Pharmacology for NDA: 209476

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

Suppliers and Packaging for NDA: 209476

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	209476	ANDA	Becton Dickinson and Company	17271-703	17271-703-06	20 BAG in 1 CASE (17271-703-06) / 500 mL in 1 BAG
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	209476	ANDA	Fresenius Kabi USA, LLC	63323-530	63323-530-75	20 BAG in 1 CASE (63323-530-75) / 500 mL in 1 BAG (63323-530-21)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	3GM/100ML
Approval Date:	Mar 13, 2019	TE:	AP	RLD:	No

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