Details for New Drug Application (NDA): 020171
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The generic ingredient in DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER is calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two 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.
Summary for 020171
Tradename: | DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER |
Applicant: | Fresenius Medcl |
Ingredient: | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate |
Patents: | 0 |
Pharmacology for NDA: 020171
Suppliers and Packaging for NDA: 020171
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | SOLUTION;INTRAPERITONEAL | 020171 | NDA | Fresenius Medical Care North America | 49230-206 | 49230-206-20 | 6 BAG in 1 CARTON (49230-206-20) / 2000 mL in 1 BAG |
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER | calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate | SOLUTION;INTRAPERITONEAL | 020171 | NDA | Fresenius Medical Care North America | 49230-206 | 49230-206-30 | 4 BAG in 1 CARTON (49230-206-30) / 3000 mL in 1 BAG |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAPERITONEAL | Strength | 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | ||||
Approval Date: | Aug 19, 1992 | TE: | AT | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAPERITONEAL | Strength | 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | ||||
Approval Date: | Aug 19, 1992 | TE: | AT | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAPERITONEAL | Strength | 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML | ||||
Approval Date: | Aug 19, 1992 | TE: | AT | RLD: | Yes |
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