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Generated: January 20, 2019

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Details for New Drug Application (NDA): 018800

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NDA 018800 describes BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, and Hospira, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in BACTERIOSTATIC 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-three suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 018800
Tradename:BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Hospira
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 018800
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018800 NDA Hospira, Inc. 0409-1966 0409-1966-05 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-05) > 20 mL in 1 VIAL, MULTI-DOSE (0409-1966-01)
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018800 NDA Hospira, Inc. 0409-1966 0409-1966-07 25 VIAL, MULTI-DOSE in 1 TRAY (0409-1966-07) > 30 mL in 1 VIAL, MULTI-DOSE (0409-1966-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Oct 29, 1982TE:APRLD:Yes

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