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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 021569


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NDA 021569 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 Cadista, Laboratorios Grifols, Liebel-flarsheim, Medefil Inc, Miles, Nephron, and Taro, and is included in twenty-eight NDAs. It is available from eighteen 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-two suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 021569
Tradename:SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Liebel-flarsheim
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021569
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 021569 NDA Liebel-Flarsheim Company LLC 0019-1188 0019-1188-27 20 BOX in 1 CARTON (0019-1188-27) > 1 SYRINGE, PLASTIC in 1 BOX > 125 mL in 1 SYRINGE, PLASTIC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 021569 NDA Liebel-Flarsheim Company LLC 0019-1188 0019-1188-81 20 BOX in 1 CARTON (0019-1188-81) > 1 SYRINGE, PLASTIC in 1 BOX > 125 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength405MG/50ML (9MG/ML)
Approval Date:Jul 27, 2006TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1012.5MG/125ML (9MG/ML)
Approval Date:Jul 27, 2006TE:RLD:Yes

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