Details for New Drug Application (NDA): 020171
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NDA 020171 describes DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, which is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from two suppliers. Additional details are available on the DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER profile page.
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. Three suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate profile page.
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. Three 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 de Mexico, S.A. de C.V. | 46163-206 | 46163-206-82 | 5 BAG in 1 CARTON (46163-206-82) / 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 de Mexico, S.A. de C.V. | 46163-206 | 46163-206-94 | 5 BAG in 1 CARTON (46163-206-94) / 2500 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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