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Generated: December 18, 2018

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Details for New Drug Application (NDA): 017609

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NDA 017609 describes NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.
Suppliers and Packaging for NDA: 017609
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER dextrose; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate INJECTABLE;INJECTION 017609 NDA Hospira, Inc. 0409-7968 0409-7968-09 12 BAG in 1 CASE (0409-7968-09) > 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Covington
Julphar
Chinese Patent Office
Express Scripts
Cerilliant
Cipla
Johnson and Johnson
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