Details for New Drug Application (NDA): 217535

NDA 217535 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 217535

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

Suppliers and Packaging for NDA: 217535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9%	sodium chloride	SOLUTION;INJECTION	217535	ANDA	Nexus Pharmaceuticals LLC	14789-133	14789-133-05	25 VIAL, GLASS in 1 CARTON (14789-133-05) / 10 mL in 1 VIAL, GLASS (14789-133-07)
SODIUM CHLORIDE 0.9%	sodium chloride	SOLUTION;INJECTION	217535	ANDA	Nexus Pharmaceuticals LLC	14789-134	14789-134-05	25 VIAL, GLASS in 1 CARTON (14789-134-05) / 20 mL in 1 VIAL, GLASS (14789-134-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	90MG/10ML (9MG/ML)
Approval Date:	Aug 23, 2023	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	180MG/20ML (9MG/ML)
Approval Date:	Aug 23, 2023	TE:	AP	RLD:	No

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