Details for New Drug Application (NDA): 202832

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NDA 202832 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.

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

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9%	sodium chloride	INJECTABLE;INJECTION	202832	NDA	Medefil, Inc.	64253-202	64253-202-30	60 SYRINGE, PLASTIC in 1 BOX (64253-202-30) / 10 mL in 1 SYRINGE, PLASTIC

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	9MG/ML (9MG/ML)
Approval Date:	Jan 6, 2012	TE:		RLD:	Yes

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	18MG/2ML (9MG/ML)
Approval Date:	Jan 6, 2012	TE:		RLD:	Yes

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	22.5MG/2.5ML (9MG/ML)
Approval Date:	Jan 6, 2012	TE:		RLD:	Yes

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