Details for New Drug Application (NDA): 201850

NDA 201850 describes SODIUM CHLORIDE 0.9%, which is a drug marketed by Medefil Inc, B Braun, Hikma, Nexus Pharms, Spectra Mdcl Devices, Baxter Hlthcare, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Laboratorios Grifols, Liebel-flarsheim, Abbott, Jubilant Cadista, Miles, Nephron, and Taro, and is included in thirty-four NDAs. It is available from five suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

Summary for 201850

Tradename:	SODIUM CHLORIDE 0.9%
Applicant:	Hikma
Ingredient:	sodium chloride
Patents:	0

Pharmacology for NDA: 201850

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

Suppliers and Packaging for NDA: 201850

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9%	sodium chloride	SOLUTION;INJECTION	201850	ANDA	Hikma Pharmaceuticals USA Inc.	0641-1512	0641-1512-36	100 AMPULE in 1 CARTON (0641-1512-36) / 10 mL in 1 AMPULE (0641-1512-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Jan 20, 2012	TE:		RLD:	No

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