Details for New Drug Application (NDA): 018803

NDA 018803 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Abbott, Baxter Hlthcare, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Jubilant Cadista, Laboratorios Grifols, Liebel-flarsheim, Miles, Nephron, and Taro, and is included in twenty-six NDAs. It is available from twenty-three suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% 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 018803

Tradename:	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Hospira
Ingredient:	sodium chloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018803

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

Suppliers and Packaging for NDA: 018803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	018803	NDA	Henry Schein, Inc.	0404-9954	0404-9954-20	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-20) / 20 mL in 1 VIAL, SINGLE-DOSE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	018803	NDA	Henry Schein, Inc.	0404-9954	0404-9954-50	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9954-50) / 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	9MG/ML
Approval Date:	Oct 29, 1982	TE:	AP	RLD:	Yes

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