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Generated: April 27, 2017

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Details for New Drug Application (NDA): 078446

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NDA 078446 describes POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by Icu Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and twenty-seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

Summary for NDA: 078446

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078446

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
potassium chloride; sodium chloride
INJECTABLE;INJECTION 078446 ANDA Hospira, Inc. 0409-9257 0409-9257-39 12 POUCH in 1 CASE (0409-9257-39) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength149MG/100ML;450MG/100ML
Approval Date:Sep 10, 2008TE:APRLD:No

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