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Generated: November 18, 2018

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Details for New Drug Application (NDA): 016366

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NDA 016366 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Abbott, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Jubilant Hollistrstr, Laboratorios Grifols, Liebel-flarsheim, Medefil Inc, Miles, and Taro, and is included in twenty-seven NDAs. It is available from seventeen 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 fifty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 016366
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Icu Medical Inc
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 016366
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 016366 NDA Hospira, Inc. 0409-7983 0409-7983-02 24 POUCH in 1 CASE (0409-7983-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 016366 NDA Hospira, Inc. 0409-7983 0409-7983-03 24 POUCH in 1 CASE (0409-7983-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength900MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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