Details for New Drug Application (NDA): 018365
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NDA 018365 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% 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 POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER profile page.
The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Summary for 018365
| Tradename: | POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | dextrose; potassium chloride; sodium chloride |
| Patents: | 0 |
Pharmacology for NDA: 018365
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 018365
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 018365 | NDA | ICU Medical Inc. | 0990-7901 | 0990-7901-09 | 12 POUCH in 1 CASE (0990-7901-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER | dextrose; potassium chloride; sodium chloride | INJECTABLE;INJECTION | 018365 | NDA | ICU Medical Inc. | 0990-7901 | 0990-7901-09 | 12 POUCH in 1 CASE (0990-7901-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;149MG/100ML;225MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;74.5MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 5, 1983 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5GM/100ML;224MG/100ML;225MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 5, 1983 | TE: | RLD: | No | |||||
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