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Details for New Drug Application (NDA): 018803

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NDA 018803 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Miles, Hospira, Taro Pharms Ireland, Fresenius Kabi Usa, Haemonetics, Abbott, Medefil Inc, Jubilant Hollistrstr, Liebel-flarsheim, and Fresenius Medcl, and is included in twenty-five NDAs. It is available from fourteen 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 three hundred and twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for NDA: 018803

Suppliers and Packaging for NDA: 018803

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
sodium chloride
INJECTABLE;INJECTION 018803 NDA Hospira, Inc. 0409-1918 0409-1918-32 50 CARTRIDGE in 1 CONTAINER (0409-1918-32) > 2 mL in 1 CARTRIDGE (0409-1918-42)
sodium chloride
INJECTABLE;INJECTION 018803 NDA Hospira, Inc. 0409-1918 0409-1918-33 25 CARTRIDGE in 1 CONTAINER (0409-1918-33) > 3 mL in 1 CARTRIDGE (0409-1918-43)

Summary for product number 001

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

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