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Generated: January 19, 2019

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Details for New Drug Application (NDA): 019759

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NDA 019759 describes SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Icu Medical Inc, and Miles, and is included in eleven NDAs. It is available from three suppliers. Additional details are available on the SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 019759
Tradename:SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Applicant:Hospira
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019759 NDA Hospira, Inc. 0409-7132 0409-7132-02 24 POUCH in 1 CASE (0409-7132-02) > 1 BAG in 1 POUCH > 250 mL in 1 BAG (0409-7132-04)
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 019759 NDA Hospira, Inc. 0409-7132 0409-7132-66 10 POUCH in 1 CASE (0409-7132-66) > 5 BAG in 1 POUCH > 50 mL in 1 BAG (0409-7132-68)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength450MG/100ML
Approval Date:Jun 8, 1988TE:APRLD:No

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