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Last Updated: May 23, 2024

Details for New Drug Application (NDA): 018314


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NDA 018314 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-six NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 018314
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018314
Suppliers and Packaging for NDA: 018314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 018314 NDA ICU Medical Inc. 0990-7972 0990-7972-08 4 POUCH in 1 CASE (0990-7972-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride SOLUTION;IRRIGATION 018314 NDA ICU Medical Inc. 0990-7972 0990-7972-05 12 BAG in 1 CASE (0990-7972-05) / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IRRIGATIONStrength900MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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