Details for New Drug Application (NDA): 211968

NDA 211968 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 211968

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

Suppliers and Packaging for NDA: 211968

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	211968	ANDA	Nephron SC Inc.	0487-4301	0487-4301-05	64 BAG in 1 CASE (0487-4301-05) / 50 mL in 1 BAG
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;INJECTION	211968	ANDA	Nephron SC Inc.	0487-4301	0487-4301-10	64 BAG in 1 CASE (0487-4301-10) / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	450MG/50ML (9MG/ML)
Approval Date:	Apr 23, 2020	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INJECTION			Strength	900MG/100ML
Approval Date:	Apr 23, 2020	TE:	AP	RLD:	No

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