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Generated: October 23, 2018

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Details for New Drug Application (NDA): 018883

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NDA 018883 describes DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER profile page.

The generic ingredient in DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There are two hundred and seventy-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.
Suppliers and Packaging for NDA: 018883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018883 NDA Fresenius Medical Care North America 49230-188 49230-188-97 5 BAG in 1 CARTON (49230-188-97) > 2500 mL in 1 BAG
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate SOLUTION;INTRAPERITONEAL 018883 NDA Fresenius Medical Care North America 49230-188 49230-188-50 2 BAG in 1 CARTON (49230-188-50) > 5000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Nov 30, 1984TE:ATRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Nov 30, 1984TE:ATRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAPERITONEALStrength25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;567MG/100ML;392MG/100ML
Approval Date:Nov 30, 1984TE:ATRLD:No

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