Details for New Drug Application (NDA): 017608
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NDA 017608 describes DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER profile page.
The generic ingredient in DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
The generic ingredient in DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
Summary for 017608
| Tradename: | DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER |
| Applicant: | Icu Medical Inc |
| Ingredient: | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate |
| Patents: | 0 |
Pharmacology for NDA: 017608
| Mechanism of Action | Osmotic Activity Phosphate Chelating Activity |
| Physiological Effect | Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption |
Suppliers and Packaging for NDA: 017608
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 017608 | NDA | ICU Medical Inc. | 0990-7929 | 0990-7929-03 | 24 POUCH in 1 CASE (0990-7929-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG |
| DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 017608 | NDA | ICU Medical Inc. | 0990-7929 | 0990-7929-09 | 12 POUCH in 1 CASE (0990-7929-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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