Details for New Drug Application (NDA): 019685
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NDA 019685 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER profile page.
The generic ingredient in POTASSIUM CHLORIDE 5MEQ 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 POTASSIUM CHLORIDE 5MEQ 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 019685
Pharmacology for NDA: 019685
| 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: 019685
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 019685 | NDA | ICU Medical Inc. | 0990-7111 | 0990-7111-09 | 12 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
| POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER | calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate | INJECTABLE;INJECTION | 019685 | NDA | ICU Medical Inc. | 0990-7111 | 0990-7111-09 | 12 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Oct 17, 1988 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Oct 17, 1988 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML | ||||
| Approval Date: | Oct 17, 1988 | TE: | RLD: | Yes | |||||
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