Details for New Drug Application (NDA): 078177

NDA 078177 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Laboratorios Grifols, Liebel-flarsheim, Abbott, Baxter Hlthcare, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-one 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-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for 078177

Tradename:	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Fresenius Medcl
Ingredient:	sodium chloride
Patents:	0

Pharmacology for NDA: 078177

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

Suppliers and Packaging for NDA: 078177

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	078177	ANDA	Fresenius Medical Care de Mexico, S.A. de C.V.	46163-300	46163-300-10	12 BAG in 1 CARTON (46163-300-10) / 1000 mL in 1 BAG
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	078177	ANDA	Fresenius Medical Care North America	49230-300	49230-300-10	12 BAG in 1 CARTON (49230-300-10) / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	900MG/100ML
Approval Date:	Apr 12, 2007	TE:	AP	RLD:	No

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