Details for New Drug Application (NDA): 208122

NDA 208122 describes SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Miles, and Otsuka Icu Medcl, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for 208122

Tradename:	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	sodium chloride
Patents:	0

Pharmacology for NDA: 208122

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

Suppliers and Packaging for NDA: 208122

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	208122	ANDA	Becton Dickinson and Company	17271-700	17271-700-02	60 BAG in 1 CASE (17271-700-02) / 50 mL in 1 BAG
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	208122	ANDA	Becton Dickinson and Company	17271-700	17271-700-03	50 BAG in 1 CASE (17271-700-03) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	450MG/100ML
Approval Date:	Jul 23, 2018	TE:	AP	RLD:	No

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